Pelvic implants and methods of making and using thereof

ABSTRACT

Pelvic implant having a frame with two arms and a sheet are disclosed. The sheet may be held under tension in the assembled implant. The implant may be planar (flat) or may be non-planar. The implant may be contoured laterally. A curved non-planar implant may be convex or concave in a rostro-caudal direction. The implants may (optionally) include two additional arms and a second sheet for supporting a urethra and/or a bladder neck. Methods for constructing and assembling the implants are disclosed. A method ultrasonically welding the frame of the implant without thermally damaging the sheet is disclosed. Methods of implantation of the implants are disclosed.

FIELD OF THE INVENTION

The present invention, in some embodiments thereof, relates to improvedpelvic implants, more particularly, but not exclusively, to implants forpreventing organ prolapse and to methods of constructing such implantsand to methods for constructing implants suitable for other medicalapplications.

BACKGROUND OF THE INVENTION

Pelvic floor disorders include cystocele, rectocele, enterocele anduterine and vaginal prolapse. These disorders are often a consequence ofweakness or damage to pelvic muscles and ligaments, caused bychildbearing, hysterectomy, connective tissue defects, atrophy, orphysical injury. Two basic approaches to remedying this condition havebeen the use of a removable device known as a pessary, or surgery toreplace or repair parts of the pelvic supporting structures.

A pessary is a vaginal insert, having a specified geometricconfiguration such as, for example, a cube or a donut, which can betemporarily placed in the vaginal canal. Examples of such devices aredisclosed in U.S. Pat. No. 6,645,137; U.S. Pat. No. 6,189,535, and manyothers.

The surgical approach includes reconstruction of the damaged supporttissue using sutures or replacement of the support tissue with animplant or device. An example of such a device is disclosed in U.S. Pat.No. 6,786,861 to Pretorius. The device disclosed therein is a slinghaving a flexible elongate member and a distensible portion, and isconfigured to be inserted dorsally between the urethra and pelvic bone,with ends of the elongate member attachable to the retropubic area orischial structures. Another such device is disclosed in U.S. Pat. No.6,755,781 to Gellman. The device disclosed therein is a medical slinghaving one or more cuts are disposed in the material. The cuts on thesling provide open areas to permit tissue ingrowth and cross linkingwhen the sling is implanted inside the body of the patient. These typesof slings and supporting devices are configured to treat urinaryincontinence rather than prolapse, and as such, they are generallylocated under the urethra or bladder neck.

Other devices for implantation within a pelvis are described. U.S. Pat.No. 6,592,515 to Thierfelder, for example, discloses an implant usefulfor a sacral colpopexy procedure for treating vaginal prolapse. Theimplant includes tissue engagement portions, which are configured foranchoring the implant into bone. World Publication WO 00/27304 to Ory etal. discloses a suspension device for treating prolapse and urinaryincontinence, including a suspension cord, non-absorbable material, andanchoring parts which are designed to be fixed by suturing or staplingmeans to implanting walls.

All of these devices require suturing to anchor the device to theanatomical structures within the pelvis. Other prolapse repair kits arecurrently available include a frameless mesh which may be anchored topelvic structures.

U.S. Pat. No. 7,981,024 to Levy discloses a suture-less implant forimplantation within a pelvis including a frame with two arms and aconnecting element connecting the two arms. A sheet or mesh is held bythe frame to support pelvic organs.

There is thus an ongoing need for improved pelvic implants. There isalso a need for effective methods for attaching the sheet or mesh to theframe of the implant without compromising the structural integrityand/or other physical and/or biological properties of the sheet or meshduring assembly of the implant.

SUMMARY OF THE INVENTION

The present application disclosed pelvic implants having a frame and asheet attached to the frame. In some embodiments of the implant, thesheet is held under tension to reduce sheet erosion and/or folding afterimplantation. In some embodiments of the implant, the frame has twoarms. In other embodiments of the implant, the frame may have four arms.In some embodiments of the implant, the implant is a non-planar implantand the frame is curved in the rostro-caudal direction such that thearms of the frame may be curved in the rostro-caudal direction. Thecurved arms of the frame may have a convex side and a concave side withrespect to the rostro-caudal axis of the implant. In such embodiments,the curvature of the arms allow the implant to better fit the curvebetween the vagina and a pelvic organ (a bladder/urethra or a rectum),which advantageously reduces post implantation pain and patientdiscomfort. For example, in accordance with an embodiment of the implantwhich may be implanted between the bladder/urethra and the vagina of thefemale pelvis, the sides of the arms of the frame facing thebladder/urethra are convexly curved and the sides of the arms facing thevagina are concavely curved. In another embodiment of the implant, whichmay be implanted between the vagina and the rectum of the female pelvis,the sides of the arms of the frame facing the rectum are convexly curvedand the sides of the arms facing the vagina are concavely curved. Inadditional embodiments of the implants (tensioned implants ornon-tensioned, planar implants or curved non-planar implants), the armsmay be bent at their distal ends such that a portion (or part) of thearms are bent at an angle towards each other. Other embodiments of theimplant have two additional arms included in the frame such that theframe has two arms for holding the sheet or mesh and the two additionalarms attached to a second (strip-like) sheet or mesh positioned tosupport the urethra which may advantageously prevent the urethra fromkinking against the vagina after implantation. Several methods forconstructing the implants are disclosed in the application, including amethod for constructing the implant by ultrasonically welding the framehalves which hold the sheet or mesh between them without damaging (bysoftening or melting the sheet or mesh) the sheet or mesh. Additionalmechanical methods for constructing the implant without the use ofthermal bonding techniques are disclosed. Methods for implanting someembodiments of the pelvic implants are also disclosed in theapplication.

There is therefore provided, in accordance with some embodiments of thedevices of the present application, a device for implantation in apelvis, the device includes a sheet having a perimeter, and a frameincluding an elastic member having a first arm and a second arm. Theelastic member has a compressed state and a relaxed state. The elasticmember is elastically bendable to change the distance between the firstarm and the second arm. The frame holds the sheet at a portion of theperimeter such that in an assembled device said sheet is held undertension.

In accordance with some embodiments of the device, the frame hascontoured lateral edges.

In accordance with some embodiments of the device, the device is a flatdevice and the frame is flat frame.

In accordance with some embodiments of the device, the device is acurved non-planar device, the frame is a non-planar frame, and the firstarm and second arm are curved to fit a curved pelvic region definedbetween a vagina and an organ of the pelvis.

In accordance with some embodiments of the device, the organ is abladder and the first arm and second arm are curved to fit a curvedpelvic region defined between the vagina and the bladder.

In accordance with some embodiments of the device, the organ is a rectumand the first arm and second arm are curved to fit a curved pelvicregion defined between the vagina and the rectum.

In accordance with some embodiments of the device, the frame has aproximal portion and a distal portion. The first arm and the second armeach have a proximal portion and a distal portion, and the proximalportions of the first arm and second arm are bent towards each other atan angle.

In accordance with some embodiments of the device, the angle is a rightangle, or an acute angle or an obtuse angle.

In accordance with some embodiments of the device, the sheet is a meshor a sheath or a diaphragm or a membrane, or a multi-layered sheet or adivider.

In accordance with some embodiments of the device, the sheet has asubstantially flat configuration.

In accordance with some embodiments of the device, the sheet has anon-planar configuration.

In accordance with some embodiments of the device, the sheet is abiocompatible sheet including a material selected from a syntheticmaterial, a polymer based material, a biological material, a collagen, abiodegradable material, and any combinations thereof.

In accordance with some embodiments of the device, in the assembleddevice a restoring force applied by the first arm and the second arm tothe sheet to hold the sheet under tension is in the range of 0.001-2Newton.

In accordance with some embodiments of the device, the frame has a firstconfiguration in which the frame is compressed, causing the sheet to beconfigured in a compressed position, and the frame has a secondconfiguration in which the frame is expanded to allow the sheet to beconfigured in an expanded position. In the expanded position the sheetis under tension.

In accordance with some embodiments of the device, the frame includes afirst half frame and a second half frame attachable to the first halfframe.

In accordance with some embodiments of the device, the first half framehas multiple recesses formed in a first side of the first half frame andthe second half frame has multiple protruding connecting membersdisposed on a first side of the second half frame. The protrudingconnecting members are positioned on the second half frame to match thepositions of the recesses of the first half-frame.

In accordance with some embodiments of the device, the protrudingconnecting members are shaped to engage with a step formed in each ofthe multiple recesses.

In accordance with some embodiments of the device, at least some of therecesses have an open passage formed therein opening on the surface ofthe second side of the first half frame and the open passage is shapedto allow an end of a connecting member to protrude beyond the surface ofthe second side of the second half frame when a connecting member isinserted into the open passage, to allow attaching of the first and thesecond half frames by thermal and/or ultrasonic welding applied to theend of the connecting member protruding beyond the surface of the secondside of the second half frame.

In accordance with some embodiments of the device, at least some of therecesses are shaped to receive the protruding connecting members thereinand to hold the connecting members in a captive manner when the firsthalf frame and the second half frame are aligned and pushed together.

In accordance with some embodiments of the device, the first half framehas a first side and the recesses are formed in the first side. Thefirst half frame has a second side having a surface, and at least someof the recesses have an open passage formed therein. The open passageopens on the surface of the second side and the open passage is shapedto allow an end of a connecting member to be inserted into the openpassage and to be captively held within the open passage afterinsertion.

In accordance with some embodiments of the device, the passage includesa first passage portion communicating with the recess and a secondpassage portion wider than the first passage portion and opening on thesurface, and at least some of the connecting members have a slotted endto allow forcing the slotted end through the first passage portion intothe second passage portion. The slotted end expands within the secondpassage portion to hold the connecting member captive within the secondpassage portion.

In accordance with some embodiments of the device, the sheet includes afirst sleeve formed at a first side of the perimeter for receiving thefirst arm therein and a second sleeve formed on a second side of theperimeter for receiving the second arm therein.

In accordance with some embodiments of the device, the first sleeve andthe second sleeve are formed by folding end portions of the sheet at thefirst side and at the second side and attaching at least part of thefolded end portions to the surface of the sheet to form the first sleeveand the second sleeve, respectively.

In accordance with some embodiments of the device, the first and secondsleeves are formed in the sheet prior to inserting the first arm and thesecond arm therein and the distance between the first sleeve and thesecond sleeve is such that the first arm and the second arm are benttowards each other prior to inserting the first arm and the second arminto the first sleeve and the second sleeve, respectively, to achievethe tensioned state of the sheet.

In accordance with some embodiments of the device, the first sleeve andsaid second sleeve are formed by folding portions of the perimeter ofsaid sheet over the said first and said second arms and attaching saidportions to the surface of said sheet, while said frame is in ascompressed state.

In accordance with some embodiments of the device, the sheet is a firstsheet. The frame also includes a third arm and a fourth arm. The devicealso includes a second sheet attached to the third arm and to the fourtharm for supporting a neck of a bladder and/or a urethra of the pelvis,to avoid prolapsing of the bladder and/or the urethra into the wall of avagina of the pelvis.

In accordance with some embodiments of the device, the area of thesecond sheet is smaller than the area of the first sheet.

In accordance with some embodiments of the device, the first sheet isconfigured for implantation in the pelvis between a vagina and abladder.

In accordance with some embodiments of the device, the first sheet isconfigured to be disposed between the bladder and the vagina and thesecond sheet is configured to be disposed between the vagina and abladder neck and/or an urethra.

In accordance with some embodiments of the device, at least one sheet ofthe first sheet and the second sheet is selected from a mesh, a sheath,a diaphragm, a membrane, a divider and a multi-layer sheet.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second is a biocompatible sheet including a materialselected from a synthetic material, a polymer based material, acollagen, a biological material, a biodegradable material, and anycombinations thereof.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet is an elastic sheet or a flexiblesheet.

In accordance with some embodiments of the device, the frame has a firstconfiguration in which the frame is compressed, causing the first sheetand the second sheet to be in a non-tensioned state, and said frame hasa second configuration in which said frame is expanded, to allow saidfirst sheet and said second sheet to be configured in a tensioned state.

In accordance with some embodiments of the device, the first arm, secondarm, third arm and fourth arm are selected from the following:

one or more of the first arm, second arm, third arm and fourth arm beingintegral portions of the frame,

one or more of the first arm, second arm, third arm and fourth arm beingan attachable part attached of the frame; and

one or more of the first arm, second arm, third arm and fourth arm beingarticulated parts of the frame.

In accordance with some embodiments of the device, in the assembleddevice the first sheet and the second sheet are held under tension.

In accordance with some embodiments of the device, in the assembleddevice the first sheet is held under tension while the second sheet isnot held under tension in the assembled device.

In accordance with some embodiments of the device, the in the assembleddevice the first sheet is held under tension while the second sheet isloose.

In accordance with some embodiments of the device, the frame includes afirst half frame and a second half frame attached to each other forsupporting the first sheet and the second sheet.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet is held between the first half frameand the second half frame.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet is attached to the frame by sleevesformed in the perimeter of the first sheet and/or of the second sheet.

There is also provided, in accordance with some embodiments of thedevices of the present application, a device for implantation in apelvis. The device includes a sheet having a perimeter, and an elasticframe having a first arm and a second arm for holding the sheet at aportion of the perimeter. The device is a curved non-planar device andthe first arm and the second arm are curved to fit a curved pelvicregion defined between a vagina and an organ of the pelvis.

In accordance with some embodiments of the device, the frame haslaterally contoured edges.

In accordance with some embodiments of the device, the organ is abladder and the first arm and second arm are curved to fit a curvedpelvic region defined between the vagina and the bladder.

In accordance with some embodiments of the device, the organ is a rectumand the first arm and second arm are curved to accommodate a curvedpelvic region defined between the vagina and the rectum.

In accordance with some embodiments of the device, the sheet is a firstsheet and the frame also includes a third arm and a fourth arm and a thedevice includes a second sheet attached to the third arm and to thefourth arm for supporting a neck of a bladder and/or a urethra fromprolapsing into the wall of the vagina.

In accordance with some embodiments of the device, the area of thesecond sheet is smaller than the area of the first sheet.

In accordance with some embodiments of the device, the first sheet isconfigured for implantation in said pelvis between a vagina and abladder.

In accordance with some embodiments of the device, the first sheet isconfigured to be disposed between said bladder and said vagina and thesecond sheet is configured to be disposed between the vagina and abladder neck and/or a urethra.

In accordance with some embodiments of the device, the second sheet isselected from a mesh, a sheath, a diaphragm, a membrane, a divider and amulti-layer sheet.

In accordance with some embodiments of the device, the second sheet is abiocompatible sheet including a material selected from a syntheticmaterial, a polymer based material, a biological material, a collagen, abiodegradable material, and any combinations thereof.

In accordance with some embodiments of the device, the second sheet isan elastic and/or a flexible sheet.

In accordance with some embodiments of the device, the frame has a firstconfiguration in which the frame is compressed causing the first sheetand the second sheet to be in a non-tensioned state. The frame has asecond configuration in which the frame is expanded to allow the firstsheet and the second sheet to be in a tensioned state.

In accordance with some embodiments of the device, the first arm, thesecond arm, the third arm and the fourth arm are selected from:

one or more of the first arm, second arm, third arm and fourth arm is anintegral portions of the frame,

one or more of the first arm, second arm, third arm and fourth arm is anattachable part attached of the frame, and

one or more of the first arm, second arm, third arm and fourth arm is anarticulated part of the frame.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet is held under tension in the assembleddevice.

In accordance with some embodiments of the device, in the assembleddevice the first sheet is held under tension while the second sheet isnot held under tension.

In accordance with some embodiments of the device, the frame includes afirst half frame and a second half frame attached to each other forsupporting the first sheet and the second sheet.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet is held between the first half frameand the second half frame.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet is attached to the frame by sleevesformed in the perimeter of at least one of the first sheet and thesecond sheet.

In accordance with some embodiments of the device, each of the first armand the second arm has a proximal portion and a distal portion, whereinthe proximal portions of the first arm and the second arm are benttowards each other at an angle.

In accordance with some embodiments of the device, the angle is a rightangle or an acute angle or an obtuse angle.

In accordance with some embodiments of the device, the sheet is a mesh,or a sheath, or a diaphragm, or a membrane or a divider, or amulti-layered sheet.

In accordance with some embodiments of the device, the sheet is abiocompatible sheet including a material selected from a syntheticmaterial, a polymer based material, a biological material, abiodegradable material, a collagen, and any combinations thereof.

In accordance with some embodiments of the device, the frame includes atleast one elastic material.

In accordance with some embodiments of the device, in the assembleddevice the sheet is held under tension by the first arm and the secondarm to reduce sagging of the sheet and organ prolapse afterimplantation.

In accordance with some embodiments of the device, the frame has a firstconfiguration in which the frame is compressed, causing the sheet to bein a non-tensioned state. The frame has a second configuration in whichthe frame is expanded, to allow the sheet to be in a tensioned state, inwhich the sheet is under tension.

In accordance with some embodiments of the device, in the assembleddevice a restoring force applied by the first arm and the second arm tothe sheet to hold the sheet under tension is in the range of 0.001-2Newton.

In accordance with some embodiments of the device, the frame includes afirst half frame and a second half frame attachable to the first halfframe.

In accordance with some embodiments of the device, the first half framehas a plurality of recesses formed in a first side of the first halfframe and the second half frame has a plurality of protruding connectingmembers disposed on a first side of the second half frame. Theprotruding connecting members are positioned on the second half frame tomatch the positions of the recesses of the first half-frame.

In accordance with some embodiments of the device, the protrudingconnecting members are shaped to engage with a step formed in each ofthe recesses.

In accordance with some embodiments of the device, the recesses have anopen passage formed therein opening on the surface of the second side ofthe first half frame. The open passage is shaped to allow an end of aconnecting member to protrude beyond the surface of the second side ofthe second half frame when a connecting member is inserted into the openpassage, to allow attaching of the first and the second half frames bythermal bonding and/or ultrasonic welding applied to the end of theconnecting members protruding beyond the surface of the second side ofthe second half frame.

In accordance with some embodiments of the device, the recesses areshaped to receive the protruding connecting members therein and to holdthe connecting members in a captive manner when the first half frame andsaid second half frame are aligned and pushed together.

In accordance with some embodiments of the device, the first half framehas a first side, the recesses are formed in the first side, The firsthalf frame has a second side having a surface. Each of the recesses hasan open passage formed therein. The open passage opens on the surface ofthe second side. The open passage is shaped to allow an end of aconnecting member to be inserted into the open passage and to be held ina captive manner within the open passage after insertion.

In accordance with some embodiments of the device, the passage includesa first passage portion communicating with the recess and a secondpassage portion wider than the first passage portion and opening on thesurface. At least some of the connecting members have a slotted end toallow forcing the slotted end through the first passage portion into thesecond passage portion. The slotted end expands within the secondpassage portion to hold the connecting member captive within the secondpassage portion.

In accordance with some embodiments of the device, the sheet includes afirst sleeve formed at a first side of the perimeter for receiving thefirst arm therein and a second sleeve formed on a second side of theperimeter for receiving the second arm therein.

In accordance with some embodiments of the device, the first sleeve andthe second sleeve are formed by folding end portions of the sheet at thefirst side and at the second side of the sheet, and attaching at leastpart of the folded end portions to the surface of the sheet to form thefirst sleeve and the second sleeve.

In accordance with some embodiments of the device, the first sleeve andsecond sleeve are formed in the sheet prior to inserting the first armand the second arm therein, respectively. The distance between the firstsleeve and the second sleeve is such that the first arm and the secondarm are bent towards each other prior to inserting the first arm and thesecond arm into the first sleeve and the second sleeve, respectively,for holding the sheet under tension after the first arm and the secondarms are unbent.

In accordance with some embodiments of the device, the first arm and thesecond arm are elastically bent towards each other to reach a compressedstate of the frame and wherein one or more sleeves of the first sleeveand the second sleeve is formed by folding a portion of the perimeter ofthe sheet over the respective arm of the first and second arms andattaching the portion to the surface of the sheet while the frame is ina compressed state and wherein the frame is relaxed into a tensionedstate of the sheet.

In accordance with some embodiments of the device, the at least one ofthe first sleeve and the second sleeve includes both of the first sleeveand the second sleeve. The first sleeve is formed by folding a firstportion of the perimeter of the sheet over the first arm and attachingthe first portion to the surface of the sheet. The second sleeve isformed by folding a second portion of the perimeter of the sheet overthe second arm and attaching the second portion to the surface of thesheet while the frame is in a compressed state and wherein the frame isrelaxed to form a tensioned state of the sheet.

In accordance with some embodiments of the device, the area of thesecond sheet is smaller than the area of the first sheet.

In accordance with some embodiments of the device, the first sheet isconfigured for implantation in the pelvis between a vagina and abladder.

In accordance with some embodiments of the device, the first sheet isconfigured to be disposed between the bladder and the vagina and thesecond sheet is configured to be disposed between the vagina and abladder neck and/or a urethra.

In accordance with some embodiments of the device, the first sheet andthe second sheet are selected from a mesh, a sheath, a diaphragm, amembrane, a divider and a multi-layer sheet.

In accordance with some embodiments of the device, the sheet is abiocompatible sheet including a material selected from a syntheticmaterial, a polymer based material, a biological material, a collagen, abiodegradable material, and any combinations thereof.

In accordance with some embodiments of the device, the frame includes anelastic frame or a flexible frame.

In accordance with some embodiments of the device, the frame has a firstconfiguration in which the frame is compressed, causing the first sheetand the second sheet to be in a tensioned state. The frame has a secondconfiguration in which the frame is expanded, to allow the first sheetand the second sheet to be in a tensioned state.

In accordance with some embodiments of the device, the first arm, secondarm, third arm and fourth arm are selected from the group of:

one or more of the first arm, second arm, third arm and fourth arm is anintegral portion of the frame,

one or more of the first arm, second arm, third arm, and fourth arm isan attachable part attached of the frame, and

one or more of the first arm, second arm, third arm and fourth arm is anarticulated part of the frame.

In accordance with some embodiments of the device, in the assembleddevice, at least one of the first sheet and the second sheet is heldunder tension.

In accordance with some embodiments of the device, in the assembleddevice the first sheet is held under tension while the second sheet isnot held under tension.

In accordance with some embodiments of the device, the frame includes afirst half frame and a second half frame attached to each other forsupporting the first sheet and the second sheet.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet is held between the first half frameand the second half frame.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet is attached to the frame by sleevesformed in the perimeter of the at least one of the first sheet and thesecond sheet.

In accordance with some embodiments of the device, the sheet alsoincludes or is coated with a material selected from a drug, apharmaceutically active composition, a biologically active material, ananti inflammatory agent, an anti-bacterial agent, an anti viral agent,an antibiotic agent, a hormone, a biologically active protein, abiologically active polypeptide, a collagen, metallic ions, enzymes,enzyme precursors, biological promoters, a slow release matrixcontaining any therapeutic agent, and/or pharmaceutical agent and/orbiologically active material, a gel matrix containing any therapeuticagent, and/or pharmaceutical agent and/or biologically active materialand any combination thereof.

In accordance with some embodiments of the device, at least one of thefirst sheet and the second sheet also includes or is coated with amaterial selected from a drug, a pharmaceutically active composition, abiologically active material, an anti inflammatory agent, ananti-bacterial agent, an anti viral agent, an antibiotic agent, ahormone, a biologically active protein, a biologically activepolypeptide, a collagen, metallic ions, enzymes, enzyme precursors,biological promoters, a slow release matrix containing any therapeuticagent, and/or pharmaceutical agent and/or biologically active material,a gel matrix containing any therapeutic agent, and/or pharmaceuticalagent and/or biologically active material and any combination thereof.

In accordance with some embodiments of the device, the frame includes amaterial selected from a polymer, a metal, a biocompatible materialPEEK, shape memory PEEK, polylactic acid, polyethylene glycol, asynthetic biomaterial, titanium, stainless steel, a shape-memory alloy,and any combination thereof.

In accordance with some embodiments of the device, one or more of thefirst arm and the second arm are selected from articulated arms,segmented arms, arms formed as an integral part of the frame, and armsthat are attached to the frame.

In accordance with some embodiments of the device, one or more arms ofthe first arm, the second arm, the third arm and the fourth arm isselected from an articulated arm, a segmented arm, an arm formed as anintegral part of said frame and an arm that is attached to said frame.

In accordance with some embodiments of the device, the device is anon-planar device, the frame is a non-planar frame and the first arm andsecond arm are rostro-caudally convex arms.

In accordance with some embodiments of the device, the device is anon-planar device, the frame is a non-planar frame and the first arm andthe second arm are rostro-caudally concave arms.

In accordance with some embodiments of the device, the organ is abladder and the first arm and second arm are rostro-caudally convex tofit a curved pelvic region defined between the vagina and the bladder.

In accordance with some embodiments of the device, the organ is a rectumand the first arm and second arm are rostro-caudally concave toaccommodate a curved pelvic region defined between the vagina and therectum.

There is also provided, in accordance with some embodiments of thedevices of the present application, a device for implantation in apelvis, the device includes a first sheet having a first perimeter and asecond sheet having a second perimeter. The device also includes a framefor holding the first sheet at a portion of the perimeter, and forholding the second sheet at a portion of the second perimeter. The frameincludes a first arm, a second arm, a third arm and a fourth arm. Thefirst arm and the second arm hold the first sheet along at least aportion of the first perimeter and the third arm and fourth arm hold thesecond sheet along at least a portion of the second perimeter.

There is also provided, in accordance with the methods of the presentapplication, a method for treating prolapse of a pelvic organ. Themethod includes providing any of the above described devices,compressing the frame into a first compressed configuration, introducingthe device through a vagina, inserting the device into a space betweenthe vagina and the pelvic organ, and expanding the frame into apartially relaxed configuration, in which configuration the sheet isheld under tension.

In accordance with some embodiments of the methods of the presentapplication, the expanding also includes anchoring the frame into ananatomical structure.

In accordance with some embodiments of the methods of the presentapplication, the compressing includes elastically bending at least aportion of the frame.

In accordance with some embodiments of the methods of the presentapplication, the expanding includes unbending at least a portion of theframe.

In accordance with some embodiments of the methods of the presentapplication, the pelvic organ is a bladder and the inserting includesinserting the device into a space between the vagina and the bladder.

In accordance with some embodiments of the methods of the presentapplication, the anatomical structure is a pelvic side-wall.

In accordance with some embodiments of the methods of the presentapplication, the pelvic organ is a rectum and the inserting includesinserting the device into a space between the vagina and the rectum.

In accordance with some embodiments of the methods of the presentapplication, the anatomical structure is a para-rectal compartment.

There is also provided, in accordance with some embodiments of themethods of the present application, a method for treating prolapse of apelvic organ, the method includes providing any of above describeddevices, compressing the frame into a first compressed configuration,introducing the device through a vagina, inserting the device into aspace between the vagina and the pelvic organ and expanding the frameinto a second partially relaxed or fully relaxed configuration.

In accordance with some embodiments of the methods of the presentapplication, the method also includes anchoring the frame into ananatomical structure.

In accordance with some embodiments of the methods of the presentapplication, the compressing includes elastically bending at least aportion of the frame.

In accordance with some embodiments of the methods of the presentapplication, the expanding includes unbending at least a portion of theframe.

In accordance with some embodiments of the methods of the presentapplication, the inserting includes inserting the device into a spacebetween the vagina and a bladder.

In accordance with some embodiments of the methods of the presentapplication, the anatomical structure is a pelvic side-wall.

In accordance with some embodiments of the methods of the presentapplication, the inserting includes inserting the device into a spacebetween the vagina and a rectum and wherein the anatomical structure isa para-rectal compartment.

There is also provided, in accordance with some embodiments of themethods of the present application, a method for attaching a sheet to asupporting frame of an implant, the method includes providing an elasticframe having a first arm and a second arm, the frame has a relaxedconfiguration, a compressed configuration and a partially relaxedconfiguration, attaching the sheet to the frame when the frame is in thecompressed configuration, and allowing the frame to relax until therelaxing of the frame is stopped by the sheet while the frame is at thepartially relaxed configuration. The frame and the sheet are configuredsuch that when the frame is in the partially relaxed configuration, thesheet is held under tension.

In accordance with some embodiments of the methods of the presentapplication, the sheet is selected from a mesh, a single sheet, amultilayered sheet, a diaphragm, a membrane and a divider.

In accordance with some embodiments of the methods of the presentapplication, the frame includes a first half frame and a second halfframe and the attaching includes disposing the sheet between the firsthalf frame and the second half frame and attaching the first half frameto the second half frame while the sheet is held between the first halfframe and the second half frame while the first half frame and thesecond half frame are in a compressed configuration.

In accordance with some embodiments of the methods of the presentapplication, the first half frame includes a plurality of recesses orthrough passages formed therein and the second half frame has aplurality of protruding connecting members and the attaching includesinserting the plurality of protruding connecting members through aplurality of openings formed in the sheet and into the plurality ofrecesses or passages of the first half frame and firmly attaching thefirst half frame to the second half frame.

In accordance with some embodiments of the methods of the presentapplication, the firmly attaching is selected from mechanicallyattaching the first half frame to the second half frame, or thermallybonding the first half frame to the second half frame, or ultrasonicallywelding the first half frame to the second half frame or gluing thefirst half frame to the second half frame.

In accordance with some embodiments of the methods of the presentapplication, the mechanically attaching includes attaching the firsthalf frame to the second half frame.

In accordance with some embodiments of the methods of the presentapplication, the attaching includes inserting the first arm into a firstsleeve formed in a first portion of the perimeter and inserting thesecond arm into a second sleeve formed in a second portion of theperimeter.

There is also provided, in accordance with some embodiments of themethods of the present application, a method for attaching a sheet to asupporting frame of an implant, the method includes:

-   -   providing a first half frame having a plurality of recesses        formed therein;        providing a second half frame having a plurality of protruding        connecting members disposed on the second half frame, the        protruding connecting members are positioned to match the        position of said recesses of the first half-frame, providing a        sheet having a perimeter and a plurality of openings formed in        the sheet, at least some of the openings are positioned to match        the position of the protruding connecting members, inserting the        plurality of protruding connecting members through the plurality        of openings of the sheet into matching recesses of the plurality        of recesses, and ultrasonically welding the first half-frame to        the second half frame by applying ultrasonic energy to at least        one of the first half frame and the second half frame to        selectively melt a portion of each of the connecting members and        to firmly attach the first and second half-frames to each other        without thermally damaging the sheet.

In accordance with some embodiments of the methods of the presentapplication, each of the recesses includes an open passage passingthrough the first half frame. The passage is configured to allow aconnecting member of the connecting members to be inserted therethroughsuch that the end of the connecting member protrudes beyond the end ofthe open passage. The ultrasonic welding is performed by selectivelyapplying ultrasonic energy to an end of each of the connecting membersthat protrudes beyond an open end of the passage to widen the protrudingend for firmly attaching the first half frame to the second half framewithout thermally damaging the sheet.

There is also provided, in accordance with some embodiments of themethods of the present application, a method for attaching a sheet to asupporting frame of an implant, the method includes the steps of:providing a first half frame having a first surface, the first halfframe includes a multiple recesses formed in the first surface,providing a second half frame having a second surface including aplurality of protruding connecting members disposed on the secondsurface, the protruding connecting members are positioned to match theposition of the recesses of the first half-frame, the connecting membersand the recesses are configured such that when the connecting membersare fully inserted into the recesses, the first surface and the secondsurface have a gap therebetween, providing a sheet having a perimeterand a plurality of openings formed in the sheet, at least some of theopenings are positioned to match the position of the protrudingconnecting members, wherein the thickness of the sheet is smaller thanthe width of the gap, inserting the plurality of protruding connectingmembers through at least some of the plurality of openings into matchingrecesses of the plurality of recesses, applying ultrasonic energy to atleast one of the first half frame and the second half frame toselectively heat at least portions of the connecting members and therecesses, and applying force to at least one of the first half frame andthe second half frame to firmly weld the connecting members to therecesses.

In accordance with some embodiments of the methods of the presentapplication, the step of applying ultrasonic energy includes applying apulse of ultrasonic energy.

In accordance with some embodiments of the methods of the presentapplication, the pulse of ultrasonic energy has a duration in the rangeof 0.1-2 seconds.

In accordance with some embodiments of the methods of the presentapplication, the step of applying force begins prior to the step ofapplying ultrasonic energy.

In accordance with some embodiments of the methods of the presentapplication, the step of applying force and the step of applyingultrasonic energy are performed simultaneously.

In accordance with some embodiments of the methods of the presentapplication, the pulse of ultrasonic energy is terminated before thestep of applying force begins, to avoid thermal damage to the sheet.

In accordance with some embodiments of the methods of the presentapplication, the method includes the step of compressing the first halfframe and the second half frame into a compressed state prior toperforming the step of inserting.

In accordance with some embodiments of the methods of the presentapplication, the first half frame and the second half frame include PEEKhaving a melting temperature of about 340° C. and the sheet includespolypropylene having a melting temperature of about 130° C.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings (in which like components aredesignated by like reference numbers) makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a schematic isometric view of a pelvic implant, in accordancewith an embodiment of the implants of the present application;

FIG. 2 is a schematic isometric exploded view of a pelvic implantincluding two half frames in accordance with an embodiment of thepresent application;

FIG. 3 is a schematic top view illustrating a “female” half frame of thepelvic implant of FIG. 2;

FIG. 4 is a schematic isometric view of the half frame of FIG. 3;

FIG. 5 is a cross sectional view of the half frame of FIG. 4 taken alongthe lines V-V;

FIG. 6 is a schematic top view illustrating a “male” half frame of thepelvic implant of FIG. 2;

FIG. 7 is a schematic isometric view of the half frame of FIG. 6;

FIG. 8 is a cross sectional view of the half frame of FIG. 6 taken alongthe lines VIII-VIII;

FIG. 9 is a schematic cross sectional view illustrating part of animplant before ultrasonic welding;

FIG. 10 is a schematic cross section view illustrating the same part ofthe implant of FIG. 9 after the ultrasonic welding;

FIG. 11 is a schematic cross sectional diagram illustrating part of animplant having two half frames in accordance with another embodiment ofthe implants of the present application shown during a first stage ofassembly of the implant;

FIG. 12 is a schematic cross sectional diagram illustrating part of animplant of FIG. 11 shown during another stage of assembly of theimplant;

FIG. 13 is a schematic flow chart illustrating the steps of a method forassembling an implant by using ultrasonic welding, in accordance with anembodiment of the methods for implant assembly of the presentapplication;

FIG. 14 is a schematic cross sectional view illustrating part of animplant configured for being mechanically assembled and using hiddenconnecting members, in accordance with another embodiment of theimplants of the present application;

FIG. 15 is a schematic cross sectional view illustrating part of animplant configured for being mechanically assembled and using throughpassing connecting members, in accordance with another embodiment of theimplants of the present application;

FIGS. 16-17 are schematic top view diagrams illustrating two differentstates of the elastic second half frame 36 of FIG. 6;

FIGS. 18, 19, 20 and 21 are schematic cross sectional views illustratingseveral steps of the assembly of a pre-tensioned implant in accordancewith an embodiment of the implant assembly methods of the presentapplication;

FIG. 22 is a schematic isometric view illustrating the pre-tensionedassembled implant formed using the method illustrated in FIGS. 18-21;

FIG. 23 is a schematic top view illustrating an implant having amonolithic frame and a mesh or sheet including sleeves, in accordancewith another embodiment of the implants of the present application;

FIG. 24 is a schematic isometric view of part of a sheet suitable foruse in some of the implants of the present application;

FIG. 25 is a schematic isometric view illustrating an implant inaccordance with yet an additional embodiment of the implants of thepresent application;

FIG. 26 is a schematic cross sectional view of the implant of FIG. 25taken along the lines XXVI-XXVI;

FIG. 27 is a schematic isometric view illustrating a curved pelvicimplant, in accordance with yet another embodiment of the implants ofthe present application;

FIG. 28 is a schematic isometric view illustrating the implant of FIG.27 disposed between a bladder and urethra and a vagina of a human femalepelvis after implantation;

FIG. 29 is a schematic isometric view illustrating a pre-tensionedimplant having bent arms, in accordance with yet another embodiment ofthe implants of the present application;

FIG. 30 is a schematic isometric view, illustrating an implant givingfour arms, in accordance with another embodiment of the implants of thepresent application; and

FIG. 31 is a schematic cross sectional view of part of an assembledimplant, in accordance with an embodiment of the implants of the presentapplication.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTIONAbbreviations

The following abbreviations are used throughout the present application:

cm—centimeter

mm—millimeter

PEEK—Polyether ether ketone

PP—Polypropylene

POP—pelvic organ prolapse

SUI—stress urinary incontinence

The present invention, in some embodiments thereof, relates to implantsfor implantation in a body, methods of constructing and assemblingimplants and to methods for implanting of the implants.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways. It is expected that during the life of a patent maturingfrom this application many new materials suitable for making implantswill be developed and the scope of the terms “frame” and “sheet” areintended to include frames and sheets or meshes made from or includingnew materials a priori. As used herein the term “about” refers to ±10%.The word “exemplary” is used herein to mean “serving as an example,instance or illustration.” Any embodiment described as “exemplary” isnot necessarily to be construed as preferred or advantageous over otherembodiments and/or to exclude the incorporation of features from otherembodiments.

The word “optionally” is used herein to mean “is provided in someembodiments and not provided in other embodiments.” Any particularembodiment of the invention may include a plurality of “optional”features unless such features conflict. The terms “comprises”,“comprising”, “includes”, “including”, “having” and their conjugatesmean “including but not limited to”. The term “consisting of” means“including and limited to”. The term “consisting essentially of” meansthat the composition, method or structure may include additionalingredients, steps and/or parts, but only if the additional ingredients,steps and/or parts do not materially alter the basic and novelcharacteristics of the claimed composition, method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

For the purposes of the present application, the term “sheet” can beunderstood to include, but is not be limited to, a mesh, sheath,diaphragm, membrane, a divider and a multi-layered sheet. When the word“mesh” is used in relation to specific exemplary embodiments of suchimplants, it is noted that a sheet as defined hereinabove may also beused instead of a mesh in making the implant.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible sub-ranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

The present application discloses sheet implants for pelvic implantationfor the treatment of hernia and pelvic organ prolapse (POP). Suchimplants typically use a soft and/or flexible and/or elastic sheet ormesh supported by a flexible elastic frame. As the frame has to havecertain desired mechanical properties (such as, for example, sufficientstrength, sufficient elasticity and flexibility) needed for supportingthe mesh, this may necessitate the use of a material or materials forconstructing the frame that have a melting point which may be muchhigher than the melting point of the mesh or sheet being supported bythe frame. Assembly of the implant may require accommodating high andeven harnessing tension throughout the length of the solid materialwithout compromising the integrity of the mesh material(s) during theprocess of attaching the mesh to the frame and thereafter (includingduring the post-implantation time). Thus, if the assembly of the implantinvolves thermal bonding methods (such as, for example, ultrasonicwelding and ironing) ensuring good bonding of frame parts holding themesh without melting the delicate mesh held between the frame parts andwithout causing undesirable thermal damage to the mesh that maycompromise the mesh's strength and postoperative performance (and/orother physical, mechanical or biological properties) which may result inimplant's inferior performance or even failure after implantation. Thus,a large difference in the melting point of the material(s) included inthe frame and mesh may thus result in certain challenges in assemblingthe implant by ultrasonic bonding or welding methods.

An advantage of some embodiments of the implants of the presentapplication is a reduced tendency for irreversible changes in the meshshape that may result in improved support for pelvic organs and whichmay reduce the probability of implant failure over time. The mesh (orsheet) sometimes sags after implantation, reducing the efficacy ofsupport provided by the implant to a bladder or another pelvic organdisposed adjacent to the vaginal canal. Additionally, some embodimentsof the implants of the present application may simplify and shorten theimplantation duration, may reduce post-implantation mesh contractionand/or post-implantation mesh erosion and may reduce patient pain afterimplantation. The inventors of the present application have discoveredthat the pelvic implants disclosed herein perform significantly betteras compared to prior art implants when the mesh or sheet thereof is heldunder tension after of the implantation.

The present application discloses novel implants as well as methods forconstructing the implants.

Reference is now made to FIG. 1 which is a schematic isometric view of apelvic implant, in accordance with an embodiment of the implants of thepresent application.

The implant 20 includes a sheet 2 and a frame 4. The sheet 2 may beattached to and held and supported by the frame 4. The sheet 2 may be aflexible member, comprised of a nylon mesh, a biological material (suchas animal tissue, for example), or any other flexible biocompatiblematerial. For example, the sheet 2 may be comprised of Prolene™, nylon,polypropylene (PP), Deklene™, polylactic acid, polyethylene glycol,polyester, synthetic biomaterials, allografts, autologous tissue,xenografts, heterografts, a collagen based sheet, or any combination ofthe above, or any other biocompatible material which is flexible andsuitable for supporting a pelvic organ. It is noted that the abovedisclosed materials may be used in any of the sheets of any of theembodiments of the implants disclosed in the present application.

The frame 4 is comprised of or may include at least one solid, elasticsupportive material, such as a polymer, a metal, or any otherbiocompatible material. For example, frame 4 may be comprised of PEEK,shape memory PEEK, polylactic acid, polyethylene glycol, syntheticbiomaterials, titanium, stainless steel, shape-memory alloys, or anycombination of the above, or any other biocompatible material which isflexible and suitable for providing support to sheet 2. In accordancewith an embodiment of the implant, frame 4 may be comprised of abiodegradable material so that over time, frame 4 will degrade and bereplaced by scar tissue which can then act as a support for the organsand/or the sheet 2. It is noted that any of the above disclosedmaterials or any combination of any of the above disclosed materials maybe used in any of the frames of any of the embodiments of the implantsdisclosed in the present application.

It is noted that, while the sheet 2 as illustrated in FIG. 1 is,preferably, a mesh, other embodiments of the implants of the presentapplication are contemplated in which the sheet 2 is implemented as asheath, a diaphragm, a divider, a membrane, or any suitable type ofmulti-layered sheet. Additionally and/or alternatively, the frame 4and/or the sheet 2, in any of the implementations disclosed in thepresent application, may be covered with or coated with any desiredmaterial or composition including any desired drug, and/orpharmaceutically active composition and/or a biologically activematerial. Examples of such materials and/or compositions may include, ananti inflammatory agent, an anti-bacterial agent, an anti viral agent,an antibiotic agent, a hormone, a biologically active protein, abiologically active polypeptide, a collagen (selected from one or moreof any of the collagen types known in the art and any combinationthereof), metallic ions, enzymes, enzyme precursors, biologicalpromoters, a slow release matrix or a gel matrix containing anytherapeutic agent(s), and/or pharmaceutical agent(s) and/or biologicallyactive material(s) including but not limited to the above disclosedagents, materials and compositions or any combination of any of theabove compositions, materials and agents.

The frame 4 may have two arms 4A and 4B. The material or materialsincluded in frame 4 are such that the frame 4 is a flexible elasticframe. The frame 4 may have a relaxed configuration (relaxed state) andmay also have a compressed configuration (compressed state) achieved byapplying a force to the arms 4A and 4B such that the arms 4A and 4Belastically deform to reduce the distance between the arm 4A and the arm4B and compress the frame 4. When the frame 4 is in the compressed stateit may operate as a spring which may exert a force trying to restore theframe 4 to the relaxed configuration or state. In accordance with anembodiment of the implant, the sheet 2 is attached to the frame 4 whilethe frame 4 is in a compressed state. After the sheet 2 is attached tothe frame 4, the arms 4A and 4B exert a force on the sheet 2 whichresults in the sheet 2 being held under tension. When the sheet 2 isattached to the frame 4, it prevents the frame 4 from returning to therelaxed state. Thus, after the attachment of the sheet 2 to the frame 4,the frame 4 is held in a compressed state by the sheet 2 and the sheet 2is held under tension by the arms 4A and 4B. The tension under which thesheet 2 is held in the assembled implant 20 advantageously stabilizesthe implant 20 and reduces post surgical sheet sagging and improves longterm pelvic organs support efficacy as compared to implants withnon-tensioned sheets.

Several methods are contemplated for attaching the sheet 2 to the frame4 such that in the assembled implant the frame 4 is at least partiallycompressed to hold the sheet 2 under tension.

In accordance with one embodiment of the method for constructing animplant, the frame comprises two half frames which are assembled andattached to each other to hold the sheet under tension there between.The attaching of the half-frames to each other may be performed usingany suitable method of attachment known in the art, such as, forexample, thermal bonding, mechanical attachment methods or gluing, as isdisclosed in detail hereinafter.

It is noted that in all the embodiments of the implants disclosed in thepresent application the opened end of the implant is referred to as theproximal end of the implant and the closed side of the implant isreferred to as the distal end of the implant. In an example, in theimplant 20 of FIG. 1, the arrow P points proximally and the arrow Dpoints distally. In other of the drawing figures (for example, FIGS. 25and 27 hereinafter) P represents the proximal side of the implant and Drepresents the distal side of the implant. In FIG. 1, the arrows L1, andL2 pointing laterally represent the lateral sides of the implant 20. Thedashed line PD represents the proximo-distal axis of the implant 20. Thedashed line LL represents a lateral axis of the implant. The axes PD andLL are orthogonal axes. The dashed line RC is orthogonal to the planedefined by the axes LL and PD and represents a rostro-caudal axis of theimplant. It is pointed out that the term rostro-caudal axis is notrelated to the precise orientation of the implant within the body and issolely used as a convenient term referring to an axis orthogonal to theplane defined by the axes LL and PD.

The implant 20 is referred to as a flat implant solely to indicate thatthe arms 4A and 4B are not curved rostro-caudally with respect to theplane defined by the axes LL and PD (but may be contoured or curvedlaterally to fit better within the pelvic walls).

Reference is now made to FIGS. 2, 3-5 and 6-8. FIG. 2 is a schematicisometric exploded view of a pelvic implant including two half frames inaccordance with an embodiment of the present application. FIG. 3 is aschematic top view illustrating a “female” half frame of the pelvicimplant of FIG. 2. FIG. 4 is a schematic isometric view of the halfframe of FIG. 3. FIG. 5 is a cross sectional view of the half frame ofFIG. 4 taken along the lines V-V; FIG. 6 is a schematic top viewillustrating a “male” half frame of the pelvic implant of FIG. 2. FIG. 7is a schematic isometric view of the half frame of FIG. 6. FIG. 8 is across sectional view of the half frame of FIG. 6 taken along the linesVIII-VIII.

It is noted that the specific dimensions (in millimeter) of FIGS. 3, 5,6 and 8 while given to demonstrate a practical example of the implantare no meant to be limiting and are given by way of example only. Any ofthe dimensions of the implants disclosed in the present application andin the drawing figures may be changed and made larger or smaller thanthe indicated dimensions. For example, it may be desirable to make theimplants in several sizes having differing dimensions to accommodate forthe natural variation in pelvic organs in different patients. Similarly,the dimensions, shapes, spacing and the number of the connecting membersand the corresponding recesses in the half frames of some embodimentsthe implants of the present application may vary from those illustratedin the drawings in order to accommodate different types of meshes and/orsheets or due to mechanical design considerations.

Turning to FIG. 2, the implant 30 includes a sheet 2, a first half frame34 and a second half frame 36. The first half frame 34 is a “female”half frame and the second half frame 36 is a “male” half frame. Thesheet 2 is held and supported between the first half frame 34 and thesecond half frame 36 as disclosed in detail hereinafter. After assemblyof the implant 30, the first half frame 34 and the second half frame 36are firmly attached to each other and the sheet 2 is firmly held therebetween. The sheet 2 may be a flexible member, comprised of a mesh, or acontiguous sheet or a partially perforated sheet and may be made fromany material or combination of materials as disclosed in detailhereinabove with respect to the sheet 2 of FIG. 1.

The first half frame 34 and the second half frame 36 may be comprised ofa solid, supportive material or materials, such as a polymer, a metal,and/or any other biocompatible material(s) or biodegradable material(s)such as any of the material(s) disclosed in detail hereinabove withrespect to the frame 4 of FIG. 1.

It is noted that while the sheet 2 as illustrated in FIG. 1 is,preferably, a mesh, other embodiments of the implant 30 are contemplatedin which the sheet 2 is implemented as a sheath, a diaphragm, a divideror any suitable type of multi-layered sheet (with or without coating asdisclosed in detail hereinabove with respect to the sheet 2 of FIG. 1).If the sheet 2 is not a mesh, the sheet 2 may have suitable perforationsdisposed along the perimeter of the sheet 2 to accommodate anyconnecting members formed in a “male” half frame (if used) as isdisclosed in detail hereinafter.

The first half frame 34 has two arms 34A and 34B and the second halfframe has to arms 36A and 36B. Turning to FIGS. 3 and 5, the first(female) half frame 34 has multiple recesses 32 formed therein. Each ofthe recesses 32 has a step-like annular contact region 38 formedtherein. Turning to FIGS. 6 and 8, the second (male) half frame 36 hasmultiple protruding connecting members 35 formed therein. The positionof each of the connecting members 35 along the half frame 36 matches theposition of a recesses 32 formed in the first half frame 34, such thatwhen the half frames 34 and 36 are aligned with each other, each of theconnecting members 35 may be inserted into a corresponding recess 32 ofthe half frame 34. Each of the connecting members 35 may have a flatcircular surface 35A at the end thereof. When the half frames 34 and 36are aligned with each other and pressed together, each of the surfaces35A of the connecting members 35 contacts the corresponding annularcontact regions 38 of the corresponding recesses 32 of the half frame34.

Typically, the dimensions M1-M9 of the half frames 34 and 36 may bewithin the following ranges: M1=70-120 mm, M2=60-100 mm, M3=40-100 mm,M4=1-5 mm, M5=2-6 mm, M6=0.5-3 mm, M7=0.5-4 mm, M8=0.5-4 mm, M9=0.4-3mm, and (M9−M8)=0.1-2 mm. (M9−M8) is the width of the step 38 (of FIG.5). However, some of the dimensions may be smaller than the lower valuesor larger than the upper values of the above indicated value ranges ifnecessary.

In accordance with one method for assembling an implant by usingultrasonic welding the following steps may be used. The second halfframe 36 is placed on a flat surface (preferably, the surface of astainless steel plate with the side having the protruding connectingmembers 35 facing upwards. A (preferably square, but other shapes of themesh may also be used) piece of mesh larger in size than the size of thesecond half frame 36 is placed over the second half frame 36 such thatthe connecting members 35 pass through the holes in the mesh. Afterplacement of the piece of mesh, the first half frame 34 is aligned withthe second half frame 36 and placed over the mesh such that theconnecting members 35 are inserted into the corresponding recesses 32 ofthe first half frame such that each surface 35A is in contact with thestep-like annular contact region 38 of the corresponding recess 32 intowhich the connecting member is inserted. A plate of an ultrasonic welderis lowered and put into firm contact with the upper surface of the firsthalf frame 34. At this stage the mesh is held between the second halfframe 36 and the first half frame 34. Ultrasonic energy is them appliedby the ultrasonic welder to ultrasonically weld the first half frame 34to the second as disclosed in detail hereinafter. After the welding iscompleted, the excess parts of the mesh protruding from the periphery ofthe assembled implant are trimmed (for example, by a suitable cuttinglaser) or cut by any other suitable trimming method known in the art toform the form the final assembled implant.

Due to the mechanical and other requirements of the implant, inaccordance with one non-limiting embodiment of the implant, the firstand second half frames 34 and 36 of the implant may be made from PEEKwhich has a melting point of about 340° C. The mesh may be made frompolypropylene (PP) which has a melting point of about 130° C. Therefore,assembly of the frame from the first half frame 34, the second halfframe 36 and the mesh by using ultrasonic welding as disclosedhereinabove is non-trivial and requires very careful tuning of theultrasound application parameters in order to achieve a firm attachmentof the first and second half frames 34 and 36 to each other withoutcausing thermal damage or melting of the polypropylene mesh due tothermal conduction of heat from the half frames 34 and 36 to the meshbeing held between them during welding.

If the opposing surfaces of the half frames are in close contact withthe sheet or the mesh and the half frames are pressed firmly to thesurface of the sheet, the ultrasonic vibrations applied to the frameduring the welding cause significant friction between the surfaces ofthe half frames contacting the sheet resulting in too much heat beingproduced at the contacting vibrating surfaces of the mesh and halfframes during the welding process. This heat will cause the mesh tobecome damaged by fully or partially melting at the area where the meshis held in firm contact between the half frames 34 and 36 resulting in acompletely or partially damaged or weakened mesh which may result ininferior mechanical performance of the mesh in supporting pelvic organsor even in complete implant failure during or after implantation. On theother hand, if too little heat is produced during welding, the resultmay be either a failure to attach the first half frame 34 to the secondhalf frame 36 or an inferior or insufficient mechanical properties ofthe attachment points which may result in undesirable implantperformance due to separation of the two half frames 34 and 36 from themesh under mechanical stresses to which the implant may be subjectedafter implantation. This problem may be exacerbated in implants in whichthe sheet or mesh is held under tension as will be described hereinafterwith respect to another embodiment of the implants of the presentapplication. In such embodiments, the tension under which the mesh isheld may result in even larger damages to the mesh resulting fromexcessive mesh heating while the mesh is constantly subjected tostretching forces applied to the mesh by the frame.

The inventors of the implants of the present application have discoveredthat it is possible to efficiently and satisfactorily ultrasonicallyweld (or thermally bond) the first half frame and the second half frameof the implants described in the present application without thermallydamaging the mesh used in the implants by avoiding close contact betweenthe sheet (or mesh) and the frame halves during the time of applicationof the ultrasonic welding pulse to the implant. This method may beimplemented by modifying the structure of the half frames to provide aspace or gap separating between the opposing surfaces of the half framesduring the application of the ultrasound to the. This space or gap orseparation results in the opposing surfaces of the half frame not beingin close and firm contact which greatly reduces the amount of frictionbetween the surfaces of the sheet and the opposing surfaces of the framehalves between which the sheet is disposed.

Reference is now made to FIGS. 9 and 10. FIG. 9 is a schematic crosssectional view illustrating part of an implant before ultrasonic weldingand FIG. 10 is a schematic cross section view illustrating the same partof the implant of FIG. 9 after the ultrasonic welding.

Turning to FIG. 9 the connecting member 35 of the half frame 36 passesthrough a hole of the mesh 2 and the flat surface 35A of the connectingmember 35 may contact the step 38 of the first half frame 34. The recess32 has a step 38 formed therein. When a connecting member 35 is insertedinto a recess 32, the flat surface 35A of the connecting member 35contacts part of the surface of the step 38 and is stopped from movingfurther into the recess 32 as the surface 35A contacts the surface ofthe step 38 The position of the step 38 within the recesses 32 and thelength of the connecting members are such that when the sheet 2 isdisposed between the frames 34 and 36 by inserting the connectingmembers 35 through holes formed in the sheet 2 (or in any mesh beingused) and the half 34 and the frame half 36 are firmly pushed together(For example by a vibrating plate of the ultrasonic welder being used),the surfaces 35A of the connecting members 35 engage in firm contactwith the steps 38 of the recesses 32 resulting in a gap 37 being leftbetween the surfaces 34A and 36A, of the half frames 34 and 36.

The dimensions of the gap 37 are such that the sheet 2 is not firmlypressed between the surfaces 34A and 36B, while the surface (s) 35A arefirmly engaged by the surface of the step 38 and in firm contacttherewith. When a short ultrasonic pulse is applied to the surface 34E,the regions of contact of the step 38 and the surfaces 35A heat and aresoftened (or may even melt or partially melt) because of the frictionresulting from their vibrations against each other, resulting in a firmconnecting between the half frames 34 and 36. By adjusting theparameters of the ultrasonic pulse delivered to the implant duringwelding (including, among others, ultrasonic pulse duration, ultrasoundfrequency, and ultrasound intensity), the amount of heat locallyproduced at the contact regions between the steps 38 and the surfaces35A may be controlled such that the heat is sufficient to melt orpartially melt the end of the connecting member 35 resulting in anadequate weld strength. However since during the application of theultrasound pulse almost no heat is produced at the surfaces of the sheet2 (due to the gap 37 preventing any firm contact between the surfaces ofthe sheet 2 and the surfaces 36D and 34D as explained above), thisprevents any thermal damage to the sheet 2. Furthermore, because of thestructure of the recesses 32 and the connecting members 35, any debrisformed during the welding is kept away from the sheet 2 furtherprotecting the sheet 2 from thermal damage by any such hot weldingdebris. It is noted that due to the short ultrasound pulse duration, atthe step of the application of mechanical force by the ultrasonic welderupper plate to the surface 36E of the first half frame 34 (which resultsin bringing the surfaces 34A and 36A in firm contact with the sheet 2),the ultrasound pulse has already ended so there is no possibility fordirect local heat generation at the surfaces of the sheet 2.

It is noted that the ultrasonic welding method as disclosed in detailhereinabove with respect to FIGS. 9 and 10 has several advantages,including the fact that the frame remains relatively smooth as theconnecting members are “hidden” inside the assembled frame and do notprotrude on the outside surface of the assembled frame. However, inaccordance with another embodiment of the present implants, the two halfframes may also be attached to each other by a “nailing” method in whichthe male half frame includes connecting member which are sufficientlylong to pass through thickness of the female half frame and in which thefemale half frame includes open passages extending there through.

Reference is now made to FIGS. 11-12. FIG. 11 is a schematic crosssectional diagram illustrating part of an implant having two half framesin accordance with another embodiment of the implants of the presentapplication shown during a first stage of assembly of the implant. FIG.12 is a schematic cross sectional diagram illustrating part of animplant of FIG. 11 shown during another stage of assembly of theimplant.

The implant 50 includes a sheet 2 as disclosed hereinabove in detail, afirst half frame 54 and a second half frame 56. The first half frame 54is similar in shape and material composition to the first half frame 34of FIG. 4, except that instead of the recesses 32 of the first halfframe 34, the first half frame 54 may include a plurality of openpassages 51 therein. Each open passage 51 may have a cylindrical hollowportion 52 opening on one side of the first half frame 54 and a secondfrustoconical portion 53 opening on a second side of the half frame 54.The second half frame 56 may be similar in shape and materialcomposition to the second half frame 36 of FIG. 8, except that insteadof the connecting members 35 of the second half frame 36, the first halfframe 54 includes a plurality of cylindrical connecting members 55therein. The diameter of the cylindrical connecting members 55 may beslightly smaller than the diameter of the cylindrical hollow portion 52of the open passage 51 such that the connecting member 55 may be easilyinserted into the hollow passage 51. The connecting members 55 arelonger than the total length of the open passage 51, such that when aconnecting member 55 is inserted into the open passage 51 the end 55A ofthe connecting member 55 extends beyond the wider open end of thefrustoconical portion 53 as may be seen in FIG. 11. The implant 56 maybe assembled by, preferably (but not obligatorily) thermal bonding usingironing or by any other suitable thermal bonding method (such as, forexample, ultrasonic welding) or a mechanical assembling method as isdisclosed in detail hereinafter.

If ultrasonic welding is used to assemble the implant 50, the secondhalf frame 56 may be placed on a flat plate (“Jig”) of the welder (notshown in FIG. 11, but see FIGS. 18-21, hereinafter), the mesh 2 may bealigned and placed on top of the second half frame 56 such that each ofthe plurality of connecting members 55 passes through a hole orperforation of the mesh 2 (as seen in FIG. 11). The first half frame 54may then be aligned with the second half frame 56 and lowered towardsthe mesh 2 until the plurality of connecting members 55 protruding fromthe mesh 2 enter into the corresponding plurality of open passages 51and protrude from the wider open end of the frustoconical portions 53 asis shown in FIG. 11. A second plate of the ultrasonic welder (not shown)may then be lowered until it contacts the ends 55A of the connectingmembers 55. Ultrasonic energy (preferably in a short pulse) may then bebriefly applied by the welder to heat the protruding ends 55A of theconnecting members 55 until they soften and/or melt and then amechanical force is applied by lowering the second (upper) welder plateto reshape and widen the ends 55A of the connecting members 55. Turningto FIG. 12, the mesh 2, the first half frame 54 and the second halfframe 56 are illustrated (in a cross sectional view) after assembly. Theend 55B of the connecting member 55 is shown as reshaped afterultrasonic welding the end 55B is no longer cylindrical in shape but hasexpanded laterally to fill in the frustoconical portion 53 (and maypossibly also have fused or partially fused with the walls of thefrustoconical portion 53 (it is noted that fusing is not shown in FIG.12 for the sake of clarity of illustration). After welding, thelaterally expanded parts 55B of the connecting members 55 firmly holdthe first half frame 54 the second half frame 56 and the mesh 2 togethersince the expanded end 55B of the welded connecting members 55 cannotpass through the cylindrical portion 52. It is noted that in FIG. 12,the mesh 2 is illustrated after it has been trimmed (by laser cutting orby any other suitable method known in the art) as disclosed in detailhereinabove.

It is noted that in embodiments of the implant using the open passages51 and corresponding connecting members 55, ultrasonic welding (or anyother suitable thermal bonding method such as ironing) may beeffectively applied for assembling the implant without causing damage tothe mesh 2 because due to the increased length of the connecting members55 (as compared to the length of the connecting members 35 of FIG. 8),the heated region at the ends 55A of the connecting members 55 isfurther away from the mesh 2 and due to the low thermal conductivity ofthe PEEK or other material of the frame very little heat may reach thesheet 2. Additionally, because during the application of ultrasound tothe ends 55A, no force is applied to the half frame 54 at all, becausethe welding plate engages only with the surfaces 55A at this stage anddoes not engage any part of the half frame 54, resulting in a gap 57existing between the surface 34D of the half frame 54 and the surface56D of the half frame 56. Consequently, the sheet 2 is not in firmcontact with the surfaces 56D and 54D and there is no friction betweenthe surfaces of the sheet 2 and the surfaces 54D and 56D and therefore,no heat is being locally directly generated at or near the sheet 2.

In accordance with yet another embodiment of the implant assemblymethods of the present application, a thermal bonding such as ironingmay be used for assembling the implants. For example, turning to FIG.11, the implant 50 may be assembled by placing the second half frame 56on a flat surface (such as, for example a stainless steel plate or Jigas disclosed hereinabove, placing the mesh 2 on the second half framesuch that the connecting members are inserted through the perforation ofthe mesh 2 and then aligning the first half frame 54 with the secondhalf frame 36 and lowering the first half frame towards the mesh 2 suchthat all the connecting members 35 are disposed within the correspondingopen passages 51 and the ends 35A of the connecting member 35 areprotruding through the wider ends of the corresponding frustoconicalportions 53. A hot flat ironing plate (not shown for the sake of clarityof illustration) may them be contacted with the ends 35A and a downwardforce is applied to the ironing plate by moving the ironing platedownward (towards the direction of the mesh 2) to cause heating and ormelting or partial melting and to widen the heated and softened ends 35Asuch that they fill the frustoconical portions 53. The movement of theironing plate may be (optionally) stopped before the lower surface ofthe ironing contacts touches the uppermost part of the first half frame54 and the hot ironing plate may then be lifted off the assembledimplant. A step of trimming the mesh laterally protruding from the sidesof the implant may be performed by laser cutting or any other trimmingmethod known in the art as disclosed hereinabove.

The ironing method described hereinabove results in the same attachingof the half frames 54 and 56 to each other with the mesh 2 firmly heldtherebetween. The sheet 2 is kept undamaged due to the length of theconnecting member 55 assisting in heat dissipation by thermal conductioninto the second half frame 56, such that the temperature of the surfacesof the half frame 56 which are in contact with the mesh 2 do not reachthe melting temperature of the mesh 2 preventing any significant thermaldamage to the mesh 2. If ironing by a hot plate and application of forceis being used to soften and/or expand and/or widen the ends 55A of theconnecting members 55 for assembly of the implant, the sheet 2 is evenbetter protected from any thermal damage because there is no ultrasoundapplication at all being used in ironing eliminating any possibility atall of ultrasonic vibrations from reaching any part of the sheet 2.Thus, ironing may actually be a preferred (though not obligatory) methodof thermally bonding half frames of the type used in the implant 50 (ofFIGS. 11-12). The parameters of the ironing (such as, for example, theironing plate temperature, the duration of ironing plate contact withthe implant, the duration and magnitude of force application) may beadjusted such that the first and the second half frames 54 and 56,respectively, may become strongly and firmly attached to each otherwithout causing thermal damage to the mesh 2. Furthermore, irrespectiveof whether ultrasonic welding or ironing is being used to assemble theimplant 50, the positions of the thermally treated ends 55A of theconnecting members connecting member away from the sheet 2 reduces thepossibility that any hot debris formed during ultrasonic welding orironing may reach the sheet 2 further reducing the possibility of thesheet 2 being thermally damaged.

It is noted that the ironing parameters may depend, inter alia, on thesize and dimensions of the implant being assembled, its thermal mass,thermal conductivity and other thermal characteristics of thematerial(s) from which the frame and mesh (or sheet) are formed.

It is noted that the “nailing” method disclosed hereinabove is notlimited to the use of thermal methods. For example, in accordance withanother method of the methods of implant assembly of the presentapplication, mechanical methods may be used for attaching the halfframes 54 and 56 to each other. Returning to FIG. 11, after the firsthalf frame 54, the second half frame 56 and the mesh 2 have beenarranged as illustrated in FIG. 11 a suitable mechanical tool (such as,for example a suitable punch or tool) may be used to mechanicallybroaden the ends 55A of the connecting members 55 to fasten the firsthalf frame 54 to the second half frame 56 (with the mesh 2 firmly heldbetween the half frames 54 and 56). Such a punch (not shown) may be anytype of punch suitable for broadening the end 55A, such as, for example,a punch having a conical end or a punch having a tapering end. Whenusing a mechanical method for assembling the two half frames 54 and 56and the mesh 2 together instead of using thermal methods (such as, interalia, ultrasonic welding and ironing) the problem of damaging the mesh 2is resolved since excessive heating that may thermally damage the mesh 2does not occur.

Reference is now made to FIG. 13 which is a schematic flow chart,illustrating the steps of a method for assembling an implant by usingultrasonic welding, in accordance with an embodiment of the methods forimplant assembly of the present application.

The method includes providing a first half frame (such as the exemplaryhalf frame 34 of FIGS. 3, 9 and 10) having a plurality of recesses (suchas the exemplary recesses 32 of FIGS. 3 and 5) formed therein (step 91).The method also includes providing a second half frame (such as theexemplary half frame 36 of FIGS. 6, 9 and 10) having a plurality ofprotruding connecting members (such as the exemplary connecting membersof FIGS. 6, 8, 9 and 10) formed therein to match the positions of therecesses of the first half-frame (step 92). The method also includesproviding a sheet (such as the exemplary sheet 2 of FIGS. 2, 9 and 10).The sheet has a perimeter (step 93). The method also includespositioning the sheet between the first half frame and the second halfframe such that the connecting members pass through a plurality ofopenings formed in the perimeter of the sheet and engage with theplurality of matching recesses to form a gap (such as for example thegap 37 of FIG. 9) between the opposing surfaces (such as the exemplaryopposing surfaces 34D and 36D of FIG. 9) of the first and the secondhalf frames, such that the sheet is disposed between the opposingsurfaces of the first half frame and the second half frame without beingin firm contact with the opposing surfaces of the first half frame andthe second half frame (step 94). The method also includes applyingultrasonic energy (in the form of ultrasonic vibrations) to at least oneof the first half frame and the second half frame to soften and/or meltat least a portion of each connecting member (step 95). The method alsoincludes applying force to at least one of the first half frame andsecond half frame to firmly attach the first half frame to the secondhalf frame without thermally damaging the sheet (step 96).

The method is suitable for attaching a sheet (such as, but not limitedto, the sheet 2 of FIG. 2) having a first melting temperature to asupporting frame (such as, but not limited to, the frame 34 of FIG. 2)having a second melting point when the second melting point issubstantially higher than the first melting temperature. In an exemplaryembodiment the half frames 34 and 36 may be made from PEEK having amelting point of about 340° C. and the sheet 2 may be a mesh formed frompolypropylene having a melting temperature of about 130° C.,necessitating the use of the above method to avoid thermal damage to thesheet 2 during ultrasonic welding of the implant.

It is noted that the method disclosed hereinabove and illustrated indetail in FIGS. 18-21 hereinafter, may be used for assembling any typeof implant requiring attachment of two half frames and a sheet or a meshheld between the two half frames by forming in the half framescorresponding connecting members and matching recesses where the contactregion between the connecting members and the recesses or open passagesmay be limited to control the amount of heat reaching the sheet or meshby thermal conduction through the heated (by ultrasonic welding or byironing/nailing as disclosed hereinabove).

It is noted that in accordance with yet other embodiments of methods forimplant assembly, the implants of the present application may beconfigured for enabling mechanical assembling thereof. Reference is nowmade to FIGS. 14 and 15. FIG. 14 is a schematic cross sectional viewillustrating part of an implant configured for being mechanicallyassembled and using hidden connecting members, in accordance withanother embodiment of the implants of the present application. FIG. 15is a schematic cross sectional view illustrating part of an implantconfigured for being mechanically assembled and using through passingconnecting members, in accordance with another embodiment of theimplants of the present application.

Turning to FIG. 14, the implant 60 includes a first (female) half frame64, a second (male) half frame 66 and a mesh 2. The first half frame 64is similar in shape and material composition to the first half frame 34of FIG. 4, except that instead of the recesses 32 of the first halfframe 34, the first half frame 64 includes a plurality of recesses 61therein. Each of the recesses 61 may have a cylindrical hollow recessportion 61A opening on one side of the first half frame 64 and a secondspherical hollow recess portion 61B extending from the cylindricalrecess portion 61A. The second half frame 66 is similar in shape andmaterial composition to the second half frame 36 of FIG. 8, except thatinstead of the connecting members 35 of the second half frame 36, thesecond half frame 66 includes a plurality of “snap-in” connectingmembers 65 therein. Each of the connecting members 65 includes acylindrical portion 65A and a spherical portion 65B extending from thecylindrical portion 65A. The diameter of the cylindrical portion 65A isslightly smaller than the diameter of the cylindrical hollow portion 61Aof the recess 61 and the diameter of the spherical portion 65B of theconnecting member 65 is slightly smaller than the diameter of thespherical hollow portion 61B of the recess 61, such that the connectingmember 65 may be accommodated within the hollow passage 61. As thematerial from which the half frame 66 and the half frame 64 are made offis elastic, when the spherical portion 65B is placed in contact with andforcefully pushed into the opening of the cylindrical hollow portion61A, the spherical portion 65B may be “snapped” into the sphericalportion 61B.

When the implant 60 is assembled, the mesh 2 may be placed on the secondhalf frame 66 such that each of the connecting members 65 is insertedinto an opening in the mesh 2. The first half frame may then be alignedand placed on top of the mesh 2, such that each of spherical portions65B of the connecting members 65 is put in contact with the opening ofthe cylindrical portion 61A of the corresponding recess 61. An adequateforce may then be applied to the half frame 64 until all the connectingmembers 65 snap into the corresponding recesses 61 to firmly attach thefirst half frame to the second half frame with the mesh 2 firmlyharnessed and held between the half frames 64 and 66. It is noted thatafter assembly of the implant 60, the connecting members 65 arecompletely hidden within the half frame 64 resulting in a relativelysmooth contour of the outer surface 64C of the half frame 64 and of theouter surface 66C of the half frame 66.

The construction and operation of such “snap-in” male/female connectorsis well known in the art and is therefore is not discussed in detailhereinafter. It is noted that the implants of the present applicationare not limited to using the particular exemplary shape and type of therecesses 61 and of the connecting members 65 of the implant 60 therecess, rather, it is contemplated that the implants of the presentapplication may use any type and shape of snap-in recesses andconnecting members known in the art.

Turning to FIG. 15, the implant 70 is adapted to use a different type ofmechanical assembly. The implant 70 includes a first (female) half frame74, a second (male) half frame 76 and the mesh 2. The first half frame74 is similar in shape and material composition to the first half frame54 of FIG. 11, except that instead of the recesses 52 of the first halfframe 54 (of FIG. 11), the first half frame 74 includes a plurality ofopen passages 71 therein. Each open passage 71 may have a cylindricalhollow portion 71A opening on one side of the first half frame 74 and asecond frustoconical hollow portion 71B opening on a second side of thehalf frame 74. The hollow frustoconical portion has a flat annularsurface 71C at the side thereof connected with the hollow cylindricalportion 71A and has an opening 71D at the side thereof opening on theouter surface 74A of the half frame 74.

The second half frame 76 is similar in general shape and materialcomposition to the second half frame 56 of FIG. 11, except that insteadof the connecting members 55 of the second half frame 56 (of FIG. 11),the second half frame 76 includes a plurality of split pin connectingmembers 75 therein. Each of the connecting members 75 has a cylindricalportion 75A having a cross-sectional diameter that is slightly smallerthan the cross-sectional diameter of the cylindrical portion 71A of therecess 71. Each of the connecting members 75 has a split head portion75B suitable for insertion into the hollow cylindrical portion 71A ofthe recess 71. Preferably (but not obligatorily), after the assembly ofthe implant 70, the end of the split head 75B is flush with the opening71B and does not protrude from the outer surface 74A of the first halfframe 74 (as seen in FIG. 15). However, in accordance with otherembodiments of the implant, the end of the split head 75B may eitherprotrude through the surface 74A or may be shorter than illustrated inFIG. 15 such that it may end lower than the opening 71D and is also notprotruding through the opening 71D and beyond the surface 74A.

When the implant 70 is being assembled, the mesh 2 may be aligned andplaced upon the second half frame 76 such that each of the connectingmembers 75 passes through on of the openings of the mesh 2. The firsthalf frame 76 may then be aligned and placed on top of the mesh 2 suchthat each of the split heads 75B is placed opposite the correspondingopening of the matching open passage 71. The first half frame 74 maythen be forcefully pushed towards the first half frame 76 such that thesplit heads 75B are forced to reduce their cross sectional perimeter andpass through the corresponding hollow cylindrical portions of the secondhalf frame 74 until they reach the frustoconical portions 71B where theymay expand to firmly attach the first half frame 74 and the second halfframe 76 such that the mesh 2 is firmly held and harnessed between thetwo half frames 74 and 76.

It is further noted that the frustoconical shape of the hollowfrustoconical portion 71B is not obligatory and that the second portionof the open passages 71 may have any suitable shape for holding thesplit head 75B (such as, for example, a cylindrical hollow portionhaving a cross-sectional diameter larger than the cross sectionaldiameter of the hollow cylindrical portion 71A). The frustoconicalportions 71B may be modified into any shape or structure suitable toreceiving therein the split heads 75B for firmly connecting the two halfframes 74 and 76.

While the embodiments of the implants disclosed hereinabove discloseexcellent implants constructed from two complementary half frames andseveral methods for harnessing and holding a sheet or mesh between thehalf frames, the sheet or mesh supported by the frame may typically bemade of a synthetic soft material that may change its shape over timedue to dynamic forces applied thereto by the surrounding organs. Theframe used in such implants provides mechanical support for the meshreducing the probability for irreversible changes in the mesh shape thatmay result in implant failure over time. However, the mesh or sheetsometimes sags after implantation, reducing the efficacy of supportprovided by the implant to a bladder or another pelvic organ disposedadjacent to the vaginal canal. In order to solve such post-implantationmesh sagging and/or post-implantation mesh folding problems theinventors have invented a novel type of implants in which the sheet ormesh is harnessed in a frame and is held under tension after theimplants assembly. In the novel implants of the present application, thesheet or mesh of the implants is held under tension also after theimplantation of the implant in the pelvis and significantly improves thepost-implantation implant's performance as is disclosed in detailhereinafter.

In accordance with an embodiment of the implants of the presentapplication, may be similar in structure to any of the implants 20, 30,40, 50, 60 and 70 disclosed hereinabove. However, during assembly of theimplants, the elastic frame or the parts of the frame (when a frame madefrom two half frames as disclosed in detail hereinabove) are compresseduntil they are in a compressed state (or compressed configuration). Thesheet or mesh may then be assembled between the half frames while thehalf frames (or, alternatively, the frame if a monolithic frame is usedas will be disclosed in detail hereinafter) are both in a compressedstate. After assembly of the implant (by any assembly method disclosedhereinabove, including, inter alia, any of the mechanical assemblymethods and thermal bonding methods), the compressed elastic frameexerts a restoring force trying to return into its relaxed state(relaxed configuration). However, since the sheet or mesh is nowattached to the frame, the sheet or mesh of the implant is tensioned bythe restoring forces exerted thereon by the frame and does not allow theframe to return to its fully relaxed state or relaxed configuration. Insuch implants, the sheet (or mesh) and the frame of the implant areunder tension.

Reference is now made to FIGS. 16 and 17 which are schematic top viewdiagrams illustrating two different states of the elastic second halfframe 36 of FIG. 6. Turning to FIG. 16, the second half frame 36 isidentical to the second half frame 36 of FIGS. 6-8. The second halfframe 36 is shown in a fully relaxed state or configuration. In thefully relaxed state illustrated in FIG. 16, the distance between theproximal ends of the arms 36A and 36B (measured as the distance betweenthe attachment passages 39A and 39B) is D1. If a compressing force isapplied to the arms 36A and 36B in the directions represented by the twoarrows F1, the elastic second half frame 36 will bend and becomecompressed resulting in the two arms 36A and 36B moving one towards theother and the distance between them shortens. Turning to FIG. 17, thesecond half frame 36 is illustrated in a compressed state (compressedconfiguration) resulting from the application of force to the half frame36. The distance between the two ends of the arms 36A and 36B is now D2(wherein D2<D1). As long as the compressing force is applied to the halfframe 36 it remains in the compressed state. Due to the elasticity ofthe half frame 36, it will act as a spring and if the compressing forceis not applied any more to the half frame 36, a restoring force RF(represented schematically by the two arrows labeled RF), will returnthe arms 36A and 36 to their former position before the half frame 36was compressed. It is noted that the distance D2 will depend on themagnitude of the compressing force F1 applied to the half frame 36.Within a certain range of forces the distance D2 will linearly depend onthe magnitude of the compressing force F1 (this range of forcemagnitudes is termed the liner range and may depend inter alia on theproperties of the material(s) forming the half frame 36. This restoringforce RF may be used to hold a sheet or mesh (such as, for example, themesh 2) held by the two half frames 36 and 34 (see FIGS. 6 and 3,respectively) under tension.

Reference is now made to FIGS. 18-21 which are schematic cross sectionalviews illustrating several steps of the assembly of a pre-tensionedimplant in accordance with an embodiment of the implant assembly methodsof the present application.

In accordance with an embodiment of the implants of the presentapplication, a method for assembling a pre-tensioned (or pre-loaded)implant may be as follows. Turning now to FIG. 18, the first (male) halfframe 36 may be compressed by applying a force thereto as explainedhereinabove. When the half frame 36 is in a compressed state (asillustrated in FIG. 17) it may be (detachably) anchored to a flat plate80 (such as, for example, a flat stainless steel plate forming the lowerpart of an ultrasonic welding device) such that the connecting members35 (not seen in the cross sectional view of FIGS. 18-21) of the halfframe 36 are facing upwards and away from the surface 80C of the plate80. The plate 80 may have two straight pins 80A and 80B which may beused to anchor the first half frame 36 to the plate 80 by inserting thepins 80A and 80B into the anchoring holes 39A and 39B, respectively ofthe half frame 36. The anchoring of the half frame 36 by the pins 80Aand 80B serves both to suitably align the half frame 36 on the plate 80and also to hold the first half frame 36 in the compressed state sincethe proximal ends of the arms 36A and 36B cannot move as they arerestrained by the pins 80A and 80B. The distance between the centrallongitudinal axes 84A and 84B of the pins 80A and 80B, respectively isD2 such that when the pins 80A and 80B are placed within the anchoringholes 39A and 39B, respectively, the half frame 36 is kept in acompressed state in which the distance between the anchoring holes 39Aand 39B of the half frame 36 is D2 (as illustrated in FIG. 17).

Turning now to FIG. 19, After anchoring the half frame 36 in thecompressed state, the mesh 2 may be aligned and placed on the half frame36 such that the connecting members 35 (not shown) pass through some ofthe openings 2A formed in the sheet 2 and protrude above the surface ofthe mesh 2. Turning to FIG. 20, after the mesh 2 is placed on the halfframe 36, the second (female) half frame 34 may be compressed andsuitably aligned and then placed on the mesh 2 by inserting the pins 80Aand 80B into the anchoring holes 41A and 41B formed at the proximal endsof the arms 34A and 34B, respectively of the half frame 34 which alsocauses the recesses 32 (not seen in the cross sectional view of FIG. 20)to be aligned opposite the corresponding connecting members 35 of thehalf frame 36. Turning now to FIG. 21, After the half frame has beenanchored by the pins 80A and 80B above the mesh 2 as describedhereinabove, the surface 82A of an ultrasonic welding plate 82 (beingpart of an ultrasonic welder which is not shown in its entirety for thesake of clarity of illustration) may be placed in contact with the topsurface of the half frame 34 as illustrated in FIG. 21. At this stage ofthe assembly of the implant, both the half frame 34 and the half frame36 are in a compressed state while the mesh 2 is not under tension. Theultrasonic welder may now be activated to apply an ultrasonic pulse tothe half frame 34 by the welding plate 82 and to lower the ultrasonicwelder plate 82 for applying force to the frame 34, after thetermination of the ultrasonic pulse in order to weld the connectingmembers 35 to the recesses 32, as disclosed hereinabove in detail withrespect to the method for assembling the implant 30. After theultrasonic welding is completed, the half frames 34 and 36 are firmlyattached to each other and hold the (un-tensioned yet) mesh 2 betweenthem.

The welding plate 82 may then be lifted off to allow access to thewelded implant. When the assembled implant is lifted off the anchoringpins 80A and 80B, the restoring force exerted by the two attached halfframes 34 and 36 acts on the mesh 2 and holds the mesh 2 under tensionas there is some slack in the mesh 2 during assembly and due to theharnessing of the mesh 2 by the two half frames 34 and 36 and theelasticity of the mesh 2, the arms of the half frames 34 and 36 cannotreturn to their fully relaxed state but may only partially relax due tothe restraining by the mesh 2. Therefore the assembled implant 90 isonly partially relaxed and the mesh 2 is now held under tension.

After the assembled implant is taken off the plate 80, the excess of themesh 2 which peripherally extends and surrounds the frame of theassembled implant may be trimmed to cut the mesh extending from theassembled margins of the assembled implant as disclosed in detailhereinabove with respect to the assembly of the implant 30.

Reference is now made to FIG. 22 which is a schematic isometric viewillustrating the pre-tensioned assembled implant formed using the methodillustrated in FIGS. 18-21. The pre-tensioned implant 90 includes thehalf frame 34, the half frame 36 and the mesh 2 assembled together asdisclosed in detail hereinabove and illustrated in FIGS. 16-21. The mesh2 of the assembled implant 90 is held under tension as the frame of theimplant 90 (comprised of the two half frames 34 and 36 firmly attachedto each other, with the mesh 2 harnessed and tensioned between them) isnot fully relaxed and is still compressed to a certain extent However,since the frame of the implant 90 is partially relaxed as compared tothe fully relaxed state of each of the half frames 34 and 36, thedistance D3 between the proximal ends of the arms 90A and 90B of theimplant 90 (measured as the distance between the centers of theanchoring holes 39A and 39B) is such that D2<D3<D1 (D3 is larger thanthe distance D2 but smaller than the distance D1 of the fully relaxedhalf frames 34 and 36).

Thus, while the parts or components included in both of the implants 30and 90 are similar, the difference between the pre-tensioned implant 90(of FIG. 22) and the non-tensioned implant 30 (of FIG. 2) is that thedistance between the proximal ends of the arms of the frames of eachimplant is different, being D1 in the implant 30 and D3 in the implant90 (with D1>D2). In addition, the assembled frame of the assembledimplant 90 is only partially relaxed and is restrained from fullyrelaxing by the mesh 2, while the frame of the assembled implant 30 isfully relaxed. Moreover, while in the implant 30 the mesh 2 is not undertension, in the pre-tensioned implant 90, the mesh 2 is held undertension.

Returning to FIGS. 3, 5, 6 and 8, it is noted that while the dimensions(in mm) of the half frames 34 and 36 represent typical dimensions of thehalf frame parts of an exemplary implant, they are exemplary only.Rather, the implants of the present application may have differentdimensions (smaller or larger than the dimensions of the implant ofFIGS. 3, 5, 6 and 8) in order to accommodate the natural anatomicalvariability of the pelvic region in different patients.

It was experimentally found in preliminary clinical tests that thetensioning of the mesh in pelvic implants that are pre-tensioned asdisclosed hereinabove is advantageous and results in highly significantimprovement of post surgical performance of pre-tensioned implants ascompared to the performance of prior art (non-tensioned) mesh implants.In a preliminary clinical study in humans initiated in 2014), thepre-tensioned pelvic implants of the present application were found tohave significantly improved post implantation performance as compared toprior art non-tensioned mesh pelvic implants. Briefly, as compared tothe literature (FDA Meta-analysis of surgical POP devices), the safetyprofile of the pre-tensioned implant is potentially better than thatreported for traditional surgical meshes. Short term follow upperformance-wise reveals comparable results to existing pelvic organprolapse (POP) treatment devices.

It is noted that the pre-tensioned implants of the present applicationas disclosed hereinabove in detail with respect to the exemplary implant90, are not limited to implants using assembly by ultrasonic welding.Rather, the pre-tensioned implants may be made and assembled using anysuitable method disclosed hereinabove with respect to any of(non-tensioned) implants 20, 30, 40, 50, 60 and 70 disclosed hereinaboveas well as other types of implants disclosed in detail hereinafter (see,for example, FIGS. 23, 24 and 25). Thus, any suitable assembly methoddisclosed herein or known in the art may be used as long as the mesh orsheet of the implant is held under tension in the resulting assembledimplant. For example, a pre-tensioned implant may be made using the mesh2 and the two half frames 54 and 56 of FIG. 11 by using thepre-tensioning method illustrated in FIGS. 18-21 such that the halfframes 54 and 56 are compressed prior to their placement on the plate 80hand held during assembly by the pins 80A and 80B. After assembly of themesh 2 and the compressed half frames 54 and 56, any of the nailingmethods disclosed in detail hereinabove may be used, including, but notlimited to, the ultrasonic nailing method, the ironing (hot plate)method, and any suitable mechanical nailing method. The resultingassembled implants will be pre-tensioned implants in accordance withadditional embodiments of the pre-tensioned implants of the presentapplication.

Similarly, an additional embodiment of pre-tensioned implants may bemade from the half frames 64 and 66 of FIG. 14 by modifying the assemblymethod to include compressing the half frames 64 and 66 during assembly(for example, by using the plate 80 and pins 80A and 80B of FIG. 18),and mechanically attaching of the half frame 64 to the half frame 66with the mesh 2 held and harnessed between the half frames 64 and 66,using the “snap in” method disclosed hereinabove, resulting in apre-tensioned implant.

Similarly, an additional embodiment of pre-tensioned implants may bemade from the half frames 74 and 76 of FIG. 15 by modifying the assemblymethod to include compressing the half frames 74 and 76 during assembly(for example, by using the plate 80 and pins 80A and 80B of FIG. 18),and mechanically attaching of the half frame 74 to the half frame 76with the mesh 2 held and harnessed between the half frames 74 and 76,using the “snap in” method disclosed hereinabove, resulting in apre-tensioned implant.

It is noted that the pre-tensioned implants of the present applicationare not limited to the specific implant assembly methods and implantcomponents disclosed in the present application and that thepre-tensioned implants contemplated in the present application mayinclude any type of pelvic implants, breast reconstructive implants,hernia implants and other implants in which a compressible elastic frameis attached to a sheet or a mesh such that after assembly of the implant(attachment of the sheet or mesh to the frame) the sheet or mesh is heldby the frame under tension.

In the pre-tensioned implants of the present application the tensionunder which the sheet or mesh of the implant is held is chosen so thatthe mesh is stretched to prevent formation of mesh folds (such folds inthe sheet or mesh may result in patient pain after implantation, and mayalso result in mesh erosion) on one hand, while preserving the vaginalnatural elasticity. Typically, in implants having a distance between theproximal arm ends of about 90 mm (in the fully relaxed state of theframe) a “preload” of about 10 mm may be typically (but notobligatorily) used. The preload P (which is related to the force underwhich the mesh is held in the partially relaxed state of the implantafter assembly of the implant) is defined as the shortening (in mm) ofthe distance between the lateral sides of the proximal ends of theframe's arms when the frame is in a compressed state during assembly.For example, for a pre-tensioned implant 90 of FIG. 22 which comprisesthe half frames 36 and 34, the distance between the lateral sides of theproximal ends of the half frame arms 36A and 36B during the fullyrelaxed state is D_(FR) (see FIG. 16), while the distance between thelateral sides of the proximal ends of the half frame arms 36A and 36Bduring the compressed state (when the half frame 36 is held compressedby the pins 80A and 80B of FIG. 18 during assembly of the implant 90) isD_(C) (see FIG. 17), and the distance between the lateral sides of theproximal ends of the frame arms 90A and 90B in the partially relaxedstate is D_(PR) (see FIG. 22). Thus, for the specific example of theimplant 90, P=D_(FR)−D_(C)=88.9 mm-78.9 mm=10 mm. After assembly of theimplant 90 is completed and the assembled implant 90 is allowed topartially relax as explained in detail hereinabove, D_(PR) is typicallymeasured to be 82-83 mm. From empirical measurements it was found thatthe force exerted on the mesh 2 by the arms of the implant 90 at thepartially relaxed state is about 0.5 Newton which satisfactorilyprevents folding of the mesh 2 and mesh erosion after implantation whilepreserving the vaginal natural elasticity after implantation of theimplant 90 in the pelvis.

It is noted that the while the preloading of 10 mm is typically suitablefor the specific exemplary implant 90, different preloading values(smaller or larger than 10 mm) may be used in other different types ofpre-tensioned implants of the present application, depending, interalia, the mechanical properties of the mesh or sheet being used in theimplant, and on the degree of tension in the sheet practicallysufficient to prevent formation of folds in the sheet while notresulting in adverse effects due to excessive limitation of the vaginalelasticity.

Similarly, it is noted that the force F_(PR) exerted on the mesh (orsheet) by the partially relaxed frame after assembly of the implant isnot limited to 0.5 Newton and may be higher or lower than 0.5 Newton,depending, inter alia, on the specific dimensions and configuration ofthe implant, the elasticity of the materials from which the frame andthe mesh (or sheet) of the implant are made, the mechanical propertiesof the mesh or sheet being used in the implant, and the preload P beingused. Typically, the force F_(PR) may be in the range of 0-2 Newton.However, the above indicated rage is not obligatory and a force F_(PR)higher or lower than the values of this range may be used in someimplants.

It is noted that the implants of the present application are not limitedto the implants having two half frames as disclosed hereinabove. Forexample, the implants disclosed herein may include a “monolithic” frame(a single unit frame) and may be assembled using assembly methodsdifferent from the methods disclosed hereinabove.

Reference is now made to FIGS. 23-24. FIG. 23 is a schematic top viewillustrating an implant having a monolithic frame and a mesh or sheetincluding sleeves, in accordance with another embodiment of the implantsof the present application. FIG. 24 is a schematic isometric view ofpart of a sheet suitable for use in some of the implants of the presentapplication. Turning to FIG. 23, the implant 100 includes a frame 104which is a flexible and elastic frame. The frame 104 may be made fromany of the elastic materials or combination of materials as disclosedhereinabove in detail for the implant 20 and 30. The implant 100 alsoincludes a sheet 102 (such as a mesh, a divider, as disclosed in detailhereinabove, a multi layered sheet, and a coated sheet), the sheet 102may be any sheet or mesh made from any of the materials disclosedhereinabove for the sheet 2.

The sheet 102 may be attached to the frame 104 by providing a piece ofsheet having a perimeter which is larger in size than the perimeter ofthe frame 104 and by suitably folding the peripheral edges of the sheet2 over the frame 104 towards the inside of the sheet regioncircumscribed by the frame 104 until they are in contact with thesurface of the region of the sheet 102 lying inside of the frame 104 andthen firmly attaching the folded edges of the sheet 102 to the portionsof the sheet 102 disposed inside of the frame 104. The folding over andattaching of the sheet 102 parts to each other forms a sleeve (such asfor example the sleeve 103 including the sleeve portions 103A and 103Bdisposed on opposing lateral sides of the sheet 102 and the sleeveportion 103C disposed on the distal portion of the sheet 102. Theattaching of the folded sheet 102 to form the sleeve 103 may beperformed by any suitable attaching method known in the art. Forexample, the attaching may be performed by ultrasonic welding (using anappropriate ultrasound pulse to avoid damage to the sheet 2), by ironingusing a hot plate, by gluing (using a suitable biocompatible glue), bysuturing or stitching, or by any other type of suitable attaching methodknown in the art.

The frame 104 is in this way enclosed within the sleeve 103 and supportsthe sheet 102. The implant 100 may be a non-tensioned implant if theframe 104 is fully relaxed during the assembly of the implant. However,in accordance with another embodiment of the implants of the presentapplication, the implant 100 may formed as a pre-tensioned implant bycompressing the elastic frame 104 and performing the folding of thesheet 102 while the frame 104 is held in a compressed state. Suchholding of the frame 104 in a compressed state may be performed by usinga plate similar to the plate 80 disclosed hereinabove and illustrated inFIG. 18 and inserting the pins 80A and 80B into respective openings 105Aand 105B formed in the proximal ends of the arms 104A and 104B of theframe 104 to retain the frame 4 in a compressed state during theassembly of the implant 100.

Alternatively and/or additionally, any other suitable methods may beused to hold the frame 104 in a compressed state, including, forexample, forming a suitable shaped recess (not shown) in the plate onwhich the implant is assembled such as to accommodate and hold the shapeof the frame 104 while it is in the proper compressed state. Such ashaped recess will hold the compressed frame in place in its compressedstate while assembly of the implant 100 is carried out as detailedhereinabove. In this method it may actually be easier to fold the sheet102. In the recessed plate method, the frame 104 is held in thecompressed state during assembly. The sheet 102 may be placed on such arecessed plate and the frame 104 may be compressed and then pushed overthe sheet 102 and into the shaped recess of the plate until it fitswithin the shaped recess. As a result of the fitting of the frame 104within the recess, the sheet 102 is forced to align with the externalwall of the shaped recess and partially folds making it easy to completethe folding of the sheet 102 over the frame 104. The assembly of thepre-tensioned implant may then be completed by attaching the foldedperimeter of the sheet 102 to the surface of the sheet 102 circumscribedwithin the frame 104 by any of the attachment methods disclosedhereinabove. Turning to FIG. 23, a portion of the sheet 102 isillustrated (without the frame 104 being shown, for the sake of clarityof illustration). The sleeve portion 103A is illustrated as having aninternal passage 103D for accommodating the respective portion of theframe 104 (not shown). The region of attachment 106 of the sheet 102 toitself forming the sleeve is schematically illustrated in FIG. 24.

In accordance with another method of assembly of the implants, thesleeves (or at least some of the sleeve portions) of the sheet 102 maybe formed prior to the assembly of the implant. For example, the lateralsleeve portions 103A and 103B may be formed in the sheet 102, prior toassembling the implant 100 by any of the suitable sleeve forming methodsdisclosed hereinabove. The frame 104 may then be added by compressingthe frame 104 and then inserting the proximal end of the arm 104A intothe opening 103D of the sleeve portion 103A and inserting the proximalend of the arm 104B into the opening of the sleeve portion 103B. Afterthe arms 104A and 104B are fully inserted into the sleeve portions 103Aand 103B, respectively, the frame 104 may be allowed to partially relax,tensioning the sheet 102. The sleeve portion 103C (of FIG. 23) may thenbe formed by folding a portion of the sheet 102 extending at the distalpart of the sheet 102 over the distal part of the frame 104 andattaching that portion of the sheet 102 to the surface of the sheet 102on the region inside the frame 104 and adjacent the distal portion ofthe frame 104 by any of the sleeve forming method disclosed hereinaboveto form the sleeve portion 103C which completes the harnessing of thesheet 102 to the frame 104 and prevents detachment of the sheet 102 fromthe frame 104 after implantation in the pelvis. It is noted that thesleeve portion 103C is not mandatory and that in other embodimentshaving a sheet with sleeves, the mesh the distal portion of the sheet ormesh need not be attached to the frame of the implant (such as, forexample, is the implant 130 of FIG. 25, hereinafter.

It is noted that the use of a monolithic frame in the implants of thepresent application is not limited to the type of frame and sheetstructure illustrated in FIGS. 23-24. Reference is now made to FIGS.25-26. FIG. 25 is a schematic isometric view illustrating an implant inaccordance with yet an additional embodiment of the implants of thepresent application. FIG. 26 is a schematic cross sectional view of theimplant of FIG. 25 Taken along the lines XXVI-XXVI. Turning now to FIG.25, the implant 130 includes a monolithic open frame 134 and a mesh 132attached to the frame 134. The frame 134 has two arm portions 134A and134B ending at the proximal open end of the frame 134 and a distalportion 134C extending between the arm portions 134A and 134B. The frame134 comprises two longitudinally extending hollow passages 139A and139B. The longitudinal passage 139A extends along part of the length ofthe arm portion 134A and is an open passage having a slit-like opening131A opening on the side surface of the arm portion 134A facing the armportion 134B. The longitudinal passage 139B extends along part of thelength of the arm portion 134B and is an open passage having a slit-likeopening 131B opening on the side surface of the arm portion 134B facingthe arm portion 134A. The arm portion 134A may have three small openpassages 135A, 135B and 135C passing through the entire thickness of thearm portion 134A from its upper surface 134U through the hollowlongitudinal passage 139A and exiting from the lower surface 134L of thearm portion 134A (best seen in detail in FIG. 26). The arm portion 134Bmay have three small open passages 135D, 135E and 135F passing throughthe entire thickness of the arm portion 134B from its upper surface 134Vthrough the hollow longitudinal passage 139B and exiting from the lowersurface 134N of the arm portion 134B (best seen in detail in FIG. 26).

The mesh 132 is a rectangular mesh and has two longitudinally extendingelongated attachment members 132A and 132B formed along two oppositesides of the mesh 132. When the mesh 132 is attached to the frame 134,the elongated attachment members 132A and 132B extend in theproximal-distal direction of the implant, as marked by the letters P(for proximal end of the implant 130) and D (for the distal end of theimplant 130). The elongated attachment member 132A may have three openpassages formed therein, each open passage of the elongated attachmentmember 132A may have a diameter identical to the diameter of thecorresponding open passages 135A, 135B and 135C of the arm portion 134Ato allow three attachment pins 137A, 137B and 137C to pass therethroughfor attachment and securing of the elongated attachment member 132Awithin the longitudinal passage 139A of the arm portion 134A. Theelongated attachment member 132B may have three open passages formedtherein, each open passage of the elongated attachment member 132B mayhave a diameter identical to the diameter of the corresponding openpassages 135D, 135E and 135F of the arm portion 134B, to allow threeattachment pins 137D, 137E and 137F to pass therethrough for attachmentand securing of the elongated attachment member 132B within thelongitudinal passage 139B of the arm portion 134B.

It is noted that due to the cross-sectional view of FIG. 26, only theopen passages 132I of the elongated attachment member 132A and the openpassages 132H of the elongated attachment member 132B are seen in FIG.26. Turning to FIG. 26, when the implant 130 is being assembled, theelongated attachment member 132A of the mesh 132 may be inserted intothe longitudinal passage 139A of the arm portion 134A through an openingin the proximal end of the arm portion 134A (the opening cannot be seenin the isometric view of FIG. 25) and the elongated attachment member132B of the mesh 132 may be inserted into the longitudinal passage 139Bof the arm portion 134B through an opening in the proximal end of thearm portion 134B (the opening cannot be seen in the isometric view ofFIG. 25). The mesh 132 may then be pushed (or alternatively pulleddistally, such that the flat portion of the mesh 132 slides through theslit-like openings 131A and 131B of the hollow longitudinal passages139A and 139B, respectively, until the mesh 132 is positioned such thatthe three open passages of the elongated attachment members 132A arealigned with the corresponding open passages 135A, 135B and 135C and thethree open passages of the elongated attachment members 132B are alignedwith the corresponding open passages 135D, 135E and 135F. The sixsecuring pins 137A-137F are then inserted through the openings135A-135F, respectively and expanded at both of their ends (for example,by mechanically nailing both ends of the securing pins or by thermallyexpanding both ends of the securing pins or by any other method known inthe art for attaching a securing pin), in a similar way to the methodsof expanding of the connecting members 55 (of FIG. 11) The securing pins137A-137F may also have a diameter that is slightly larger than thediameter of open passages 135A-135F and may be forced into the openpassages 135A-135F under strain. Alternatively, the securing pins137A-137F may be threaded or screw-like in shape and may be screwed intothe open passages 135A-135F (and the open passages 132I and 132H).

After the securing pins 137A-137F are fixedly attached and firmlysecured to the arm portions 134A and 134B, the mesh 132 is securely andfirmly attached within the frame 134. It is noted that the number of thesecuring pins need not be six but may be smaller or larger than six.Furthermore, while the elongated attachment members 132A and 132Bpreferably have a circular cross section and the two longitudinallyextending hollow passages 139A and 139B preferably have a generallycircular (hollow) cross sectional shape to receive the elongatedattachment members 132A and 132B therein, this is not obligatory and thecross sectional shapes of longitudinally extending hollow passages 139Aand 139B and of the elongated attachment members 132A and 132B may be ofany suitable shape (such as, for example, elliptical shape, T-shape,rectangular shape, polygonal shape, or any other suitable shape) as longas the shape is suitable to effectively hold the elongated attachmentmembers 132A and 132B captive within the longitudinally extending hollowpassages 139A and 139B, respectively, after assembly of the implant andafter implantation in the body.

It is noted that, as may be seen in FIG. 25, the rectangular (or nearlyrectangular) mesh 132 does not span the entire area defined by the frame134 and the region 133 at the distal end is not covered by the mesh 132.This does not adversely affect the performance of the implant 130 butmakes it easier and more convenient to attach the mesh 132 to the frame134 without causing undesired formation folds in the mesh 132. It isfurther noted that while the frame 134 may be a flat frame, otherembodiments of implants using a mesh attachment method similar to theattachment method disclosed with respect to the implant 130 may includecurved frames (such as, for example, the curved frame 124 of the implant120 illustrated in FIG. 27 hereinafter). Additionally, the implant 130may be a non-tensioned implant but may also be assembled as apre-tensioned implant by suitably selecting the width W of therectangular mesh 132 such that is smaller than the distance between thearm portions 134A and 134B when the frame 134 is fully relaxed. Whensuch a pre-tensioned implant is assembled, the frame 134 is firstcompressed and held in a compressed state and the mesh 132 is thenattached to the frame as disclosed in detail hereinabove and securedwith the securing pins 137A-137F as disclosed hereinabove. Afterassembly, the frame is allowed to expand but may only partially relaxdue to the restraining by the shorter width of the mesh 132, resultingin a pre-tensioned implant.

Similarly, the implant 130 may be modified by including therein twoadditional distally extending arms and a second strap-like mesh (suchas, for example, the arms 164C and 164D and the second mesh 168 of FIG.30 hereinafter), and/or by including therein additional portions orparts of the arms 134A and 134B that are bent towards each other at anangle α (such as, for example, the bent arm portions 144D and 144E ofthe implant 140 of FIG. 29, hereinafter).

It is also noted that the method of fixating or securing the mesh 132 tothe frame, is not limited to using securing pins and correspondingpassages in the arms of the frames as illustrated in FIG. 25. Rather,any other suitable type of method, known in the art for attaching themesh 132 firmly to the frame 134 may be used. For example, crimping,riveting, gluing with a biocompatible glue, or any other suitable typeof securing method known in the art may be used to attach the mesh 132to the frame 134 to prevent longitudinal sliding of the elongatedattachment members 132A and 132B within the longitudinally extendinghollow passages 139A and 139B, respectively.

It is noted that while in the implants 20, 30, 50, 60 and 70 disclosedhereinabove, the frame of the implant holding the sheet or mesh is flatframe resulting in a substantially flat (planar) implant, this is notobligatory for practicing the invention. The inventor of the implants ofthe present application has invented an additional embodiment of theimplants which further improves the performance of pelvic implants. Oneof the problems encountered in the use of flat or planar implants isthat such implants under the forces applied to the implant by prolapsingorgans (such as, for example the bladder and or urethra) may be pusheddownward towards the vagina which may result in pain to the patient andmay compromise the natural vaginal elasticity. It was found that bysuitably curving the frame of the implants it is possible to provide asignificantly better fit of the implants to the naturally occurringcurvature of the space defined between the vaginal outer surface and thesurfaces of the bladder and urethra overlying the vagina.

Reference is now made to FIGS. 27-28. FIG. 27 is a schematic isometricview illustrating a curved pelvic implant, in accordance with yetanother embodiment of the implants of the present application. FIG. 28is a schematic isometric view illustrating the implant 120 of FIG. 27disposed between a bladder and urethra and a vagina of a human female'spelvis after implantation.

The implant 120 comprises a frame 124 and a sheet 122 firmly attached tothe frame 124. The frame 124 may be an open frame and has a distal(closed) side represented in FIG. 26 by the character “D” and a proximal(open) side represented in FIG. 26 by the character “P”. The frame 124has two arm portions 124A and 124B and a contoured distal portion 124C.The frame 124 is a flexible elastic frame and may be made from any ofthe materials disclosed hereinabove with respect to the frames of theimplants 20 and 30 of FIGS. 1 and 2, respectively. The mesh 122 is asoft and flexible mesh which may be made from any of the materialsdisclosed hereinabove for making the mesh 2 of FIGS. 1 and 2. Forexample, the frame 124 may (optionally) be made from PEEK and the mesh122 may be made from PP, as disclosed hereinabove.

The mesh 122 may be attached to the frame 124 by using any of the mesh(or sheet) attachment methods disclosed hereinabove with respect to anyof the implants disclosed hereinabove with suitable modification of themethod to allow for the curved form of the implant. While the flat(planar) implants disclosed hereinabove may be laterally contoured tobetter fit the implant in the pelvis after implantation (as best seen inFIGS. 1-3), in the implant 120 the portions 124A and 124B of the frame124 may be contoured laterally and are also curved such that the frame124 is non-planar (not flat) in structure such as to achieve a betterfit of the implant 120 in the curved space between the bladder and thevagina. If the frame 124 is viewed from a lateral side (such as, forexample, in the direction of the arrow 117, the arm portions 124A and124B are seen as curved rostro-caudally and have a convex shape suchthat the frame 124 is not flat (not planar).

When the mesh 122 is attached to the curved arm portions 124A and 124B,the curvature results in the mesh 122 also being curved in threedimensional (3D) space resulting in a generally “saddle like” shape. Theprecise shape of the mesh 122 in three dimensional space may depend,inter alia, on the dimensions of the frame 124, the state of the mesh122 (tensioned or not tensioned by the frame 124), the tension or forcesexerted by the frame 124 on the mesh 122, if the mesh 122 ispre-tensioned), the elasticity of the frame 124 and of the mesh 122, andon other mechanical parameters such as the type and structure of theattachment of the mesh 122 to the frame 124. However, The overall fit ofthe implant 120 within the curved space available between the bladderand urethra and the vagina is significantly better than the fit of anyof the flat implants disclosed hereinabove (such as, for example, theimplants 20 and 30).

Turning to FIG. 28, after implantation, the implant 120 is disposed inthe space defined between the bladder 110 and urethra 112 and the vagina123. An ovary 118, a fallopian tube 116 and the urethers 115A and 115Bentering the bladder 110 are illustrated for the purpose of clarifyingthe local female pelvic anatomy in relation to the implant'spositioning. Due to the space between the above organs being curved andthe curvature of the implant 120 which is shaped to follow the curvatureof the space between these organs, the implant 120 reduces or eveneliminates any pressure on the bladder, urethra and the vagina by thesheet or mesh being used in the curved implant and may reduce theincidence of post implantation complications such as limiting orreducing the vaginal elasticity with the accompanying patientdiscomfort, and/or stress urinary incontinence (SUI), as compared to theincidence of such complications when flat implants are being used.

It is noted that the frame 124 of the implant 120 may be constructedusing any of the frame construction types, disclosed hereinabove for anyof the flat implants of the application. For example, the frame 124 maybe made from two suitably curved frame halves (not shown in FIG. 27)attachable to each other with the mesh 122 harnessed and held betweenthe two complementary frame halves. Such curved frame halves may befirmly attached to each other to form the frame 124 by using any of theattachment methods disclosed hereinabove for the flat implants (such as,but not limited to, thermal bonding methods, ultrasonic welding,ironing, nailing methods and any other attachment method making use ofconnecting members and matching recesses and/or openings, and any othermechanical attachment methods known in the art such as “snap in”,mechanical nailing connector members and gluing).

It is further noted that the frame 124 may be formed as a monolithicframe and the mesh 122 may be attached to the frame by folding andattachment of suitable portions of the mesh 122 to form one or moresleeves enfolding the arm portions 124A and 124B therein (and,optionally, also the frame portion 124C in some embodiments). It mayalso be possible to use a curved monolithic frame (not shown in detail)having a suitably shaped longitudinal recess formed therein to receiveand hold captive a suitably shaped margin portion formed on theperimeter of the mesh 122 similar to the attachment method illustratedto the flat implant of FIGS. 25-26.

Furthermore, the curved implants of the present application may benon-tensioned but may also (preferably) be pre-tensioned curved implantsin which the frame of the implant is compressed during implant assemblyand partially relaxed after assembly, exerting a force of the mesh 122to hold the mesh of the implant under tension.

When assembling such a curved pre-tensioned implant including a curvedmale half frame and a curved female half frame by using an ultrasonicwelding method, the plates of the ultrasonic welding jig may have to besuitably curved to enable accommodating the curved implant parts duringthe implant assembly.

Similar modifications may have to be made to any assembly jig usedassembling a curved implant by any of the assembling methods disclosedhereinabove with respect to assembling different types of flat implants.For example, a suitably curved base plate and a suitably curved ironinghot plate may have to be used to assemble curved implants havingmatching curved half frames attachable by any of the types of nailingmethods disclosed hereinabove. Similarly, a suitably curved ultrasonicjig plate or plated may have to be used for ultrasonically welding acurved implant having two curved half frames as disclosed hereinabove.Such modification of assembly jigs by replacing the flat plates havingplanar surfaces (such as, for example, the lower plate 80 and thewelding plate 82 of FIGS. 18-21) of any of the above disclosed assemblyjigs by plates or other members having suitably curved surfaces foraccommodating the curvature of the implant or the curvature of anycurved half frames being used to assemble the curved implant, will beeasily constructed and operated by the person skilled in the art withoutundue experimentation.

It is noted that the curvature of any of the curved implants of thepresent application may be adapted to the type and arrangement of organsbetween which the sheet or mesh of the implant is disposed. For example,if the curved implant is implanted between a vagina and a bladder, thecurvature of the implant's arms may be configured to fit the naturalcurvature between the bladder and the vagina. If the implant is to beimplanted between a vagina and a rectum (in a para-rectal compartment)of a patient, the curvature of the arms of the implant may be configuredto fit the natural curvature between the rectum and the vagina.

Reference is now made to FIG. 29 which is a schematic isometric viewillustrating a pre-tensioned implant having bent arms, in accordancewith yet another embodiment of the implants of the present application.The implant 140 includes a frame 144 and a mesh 142 firmly attached tothe frame 144. The frame 144 is generally similar in shape to the frame4 of FIG. 1 except that the proximal ends 144D and 144E of the lateralframe arms 144A and 144B, respectively are bent at an angle towards eachother.

The bent proximal ends 144D and 144E of the frame 144 may be implementedas integral portions of the frame 144 or alternatively may beimplemented as separate parts of the frame 144 and may be attached tothe portions 144A and 144B of the frame by any suitable attachmentmethod known in the art (such as, for example, welding, thermal bonding,gluing, and snap-in mechanical connectors). The mesh 142 may be similarto the sheet 2 of the implant 30 except that it may (optionally) includesemi-circular notch 142A formed therein to better accommodate the cervixof the uterus 114. However, in other embodiments of the implant of FIG.28, the proximal end of the mesh 122 may be similar to the proximal endof the sheet 2 of FIG. 1 and does not include the notch 142A. The bentproximal ends 144D and 144E of the frame 144 may improve the harnessingof the mesh 142 and may provide better support of the mesh 142 by theframe 144. Additionally, the partial closing of the wide proximalopening at the proximal end of the implant 140 by the bent proximalportions 144D and 144E provides better support to the cervix 117 and/orthe uterus 114 which are located at the proximal edge of the mesh 142.The extensions (bent proximal ends) of the frame arms provide support tothe vaginal apex or cervix since they are located in the most proximalpart of the device. Such bent proximal ends of the frame's arms areconfigured to simulate the cardinal ligaments which provide lateralsupport to the uterus.

It is noted that the length of the bent proximal portions 144D and 144Eare not limited to the length illustrated in FIG. 29. Rather, the lengthof the bent proximal portions 144D and 144E may be of any suitablelength to adapt the implant to any natural anatomical variation of thefemale uterus and cervix. Furthermore, the bent portions 144D and 144Emay be extended such that they almost touch each other or even such thatthey do touch each other, depending, inter alia, on the particularmedical application for which the implant is intended.

It is noted that while the angle α (alpha) between the portion 144A and144D and between the portion 144B and 144E, may be a right angle asillustrated in FIG. 28, in other embodiments of the implants, the angleα may also be an acute angle (smaller than 90 degrees) or an obtuseangle (larger than 90 degrees).

It is further noted that any of the flat implants disclosed hereinabove(such as, but not limited to, the implants 20 and 30) may also bemodified to include bent portions disposed at the proximal ends of thearms of the frame of the implant to improve support of the mesh or sheetof the implant and consequently the support of pelvic organs.

Reference is now made to FIG. 30 which is a schematic isometric view,illustrating an implant having four arms, in accordance with anotherembodiment of the implants of the present application. The implant 160includes a frame 164, a first sheet 162 and a second sheet 168. Theframe 164 includes a first arm 164A, a second arm 164B, a third arm 164Cand a fourth arm 164D. The first arm 164A and the second arm 164B arefirmly attached to the first sheet 162 and harness and support the firstsheet 162. The third arm 164D and the fourth arm 164E are firmlyattached to the second sheet 168 and harness and support the secondsheet 168, therebetween. The frame 164 may be made from any of theflexible elastic materials disclosed hereinabove with respect to theframe 4 of FIG. 1, and the sheets 162 and 168 may be made from any ofthe materials disclosed hereinabove with respect to the sheet 2 of theimplants 20 and 30. The second sheet 168 may (optionally) be shaped as astrap. After implantation, the second sheet 168 may be disposed betweenthe vagina 123 and the urethra 112 for supporting the urethra. The firstsheet 162 may be shaped similar to the shape of the sheet 2 of theimplants 20 and 30. In use, the frame 164 may have a first configurationin which the frame is compressed, causing the first sheet 162 and thesecond sheet 168 to be in a non-tensioned state, and a secondconfiguration in which the frame 164 is expanded (relaxed), to allow thefirst sheet 162 and the second sheet 168 to be in a tensioned state.

After implantation of the implant 160, the first sheet 162 may bedisposed, between the vagina 123 and the bladder 110 for supporting theprolapsed bladder 110. The implant 160 may be particularly well suitedfor implantation in cases of patients suffering from stress urinaryincontinence (SUI) combined with pelvic organ prolapsed (POP). As thestrap-like second sheet 168 is disposed under and support the urethra112. Typically, in cases of SUI, increased intra-abdominal pressure maycause hypermobility of the urethra 112 leading to urine leakage. Theimproved support of the urethra 112 provided by the second sheet 168 ofthe implant 160 may therefore reduce or eliminate urine leakage in casesof stress urinary incontinence, while the support of the bladder 110 bythe first sheet 162 may stabilize the prolapsed bladder 110.

It is noted that any of the suitable methods for implant assemblydisclosed hereinabove may be adapted for use in constructing the implant160 disclosed hereinabove. Thus, the frame 164 may be a monolithic frameand the first sheet 162 and second sheet 168 may have suitable sleevesformed therein, such that the first arm 164A and the second arm 164B maybe held within the sleeves formed in the first sheet 162 and the thirdarm 164D and the fourth arm 164E may be held within sleeves formed inthe second sheet 168 in a way similar to the attachment of the framearms 104 A and 104B of the implant 100 are held by the sleeves 103A and103B of the mesh 102. Alternatively, the frame 164 may be constructed oftwo male and female half frames structured and assembled using any ofthe methods disclosed hereinabove to form the frame 164 with the firstsheet 162 firmly held between the first and second arms 164A and 164Band with the second sheet 168 firmly held between the third and fourtharms 164D and 164E. In addition, embodiments of the four armed implant164 may be non-tensioned or pre-tensioned, including implant embodimentsin which both the first sheet 162 and the second sheet 168 are heldunder tension, implant embodiments in which the first sheet 162 is heldunder tension and the second sheet 168 is not held under tension,implant embodiments in which the first sheet 162 is non-tensioned andthe second sheet 168 is tensioned and implant embodiments in which boththe first sheet 162 and the second sheet 168 are non-tensioned.

It is also noted that further embodiments of the four armed implants ofthe present invention may include implants in which the proximal ends ofthe first arm and the second arm are bent at an angle α towards eachother as disclosed hereinabove for the implant 140 (of FIG. 29).Furthermore, embodiments of the four armed implants may be implementedas flat implants, but may also be shaped as curved implants in whicheither the first and second (proximal) arms of the implant are curved,or the third and fourth (distal) arms of the implant are curved, or boththe first and second arms and the third and fourth arms of the implantare curved in order to improve the fit of the implant between the vagina123 and the bladder 110 and urethra 112.

It is noted that in implants embodiments in which the implant framecomprises two half frames as disclosed hereinabove, the female and malehalf frames may be shaped such that their surfaces facing each other inthe frame regions between adjacent connecting members (of the male halfframe) or between the recesses (of the female half frame are modified toimprove the harnessing of the sheet of the implant between the male andfemale half frames.

Reference is made to FIG. 31, which is a schematic cross sectional viewillustrating part of an assembled implant, in accordance with anotherembodiment of the implants of the present application. The implant 180includes a (female) half frame 184 and a (male) half frame 186. Theimplant 180 also includes a sheet 182. The half frame 184 has an outersurface 184A and an inner surface 184B. The half frame 186 has an outersurface 186A and an inner surface 186B. In the assembled implant 180,the inner surface 186A of the half frame 186 faces towards the innersurface 184B of the half frame 184 and the sheet 2 is disposed betweenthe surfaces 186B and 184B. The half frame 186 has a “bulge” or aprotruding portion 186C that may have a semicircular cross-sectionalshape. The protruding portion 186 may extend longitudinally along thehalf frame 186 in the portions thereof lacking any connecting members(such as, for example, protruding members similar to the protrudingmembers 35 of FIG. 8). The half frame 184 has a recessed portion 184Cthat may have a semicircular cross-sectional shape which is shaped toreceive therein the protruding portion 186C when the implant 180 isassembled. The recessed portion 184C may extend longitudinally along thehalf frame 184 in the portions thereof lacking recesses shaped toreceive therein the connecting members of the half frame 186 (such as,for example recesses similar to the recesses 32 of FIG. 5).

When the implant 180 is assembled, the protruding portion 186C isdisposed within the matching recessed portion 184C and the sheet 182 istightly held between the recessed portion 184C and the protrudingportion 186C. As substantial portions of the inner surfaces 186B and184B are convexly and concavely curved, respectively, the contact areabetween the inner surface 186B and the opposing surface of the sheet 182is substantially larger as compared to the contact area achievable hadthe inner surface been planar (and not convexly curved). Similarly, thecontact area between the inner surface 184B and the opposing surface ofthe sheet 182 is substantially larger as compared to the contact areaachievable had the inner surface been planar (and not concavely curved).Thus, the arrangement of the curved surfaces (or protruding and recessedsurfaces) provides a higher friction between the contacting surfaces ofthe sheet 182 and the inner surfaces 184B and 186B than the frictionthat is achievable with flat (planar) surfaces. This configuration ofthe contact surfaces therefore improves the harnessing of the sheet 182by the frame of the implant 180 resulting in an augmented gripping ofthe sheet 182 by the half frames 186 and 184.

It is noted that the specific shape of the surfaces 186B and 184B andthe surfaces 186C and 184C illustrated in FIG. 31 is not obligatory.Rather, any type of matching protruding and recessed portions may beused, such as inner surface portions having a protruding and recessedtriangular cross sectional shapes, rectangular cross sectional shapes,or any other non planar surfaces of such protruding and matchingrecessed surfaces may be used in the half frames of the implants of thepresent application.

It is noted that the present application is contemplates to includes anytype of combination of the features and structural components of theimplants disclosed in the present application unless they are mutuallyexclusive or incompatible with each other. For example, the flat implant20 may or may not include the bent arm portions or parts (such as, forexample, bent arms similar to the bent arm portions 144D and 144E of theimplant 140) by suitably modifying the proximal ends of the arms of theframe 4. Similarly, the sheet 2 of the implant 20 (FIG. 1) may be arectangular or nearly rectangular mesh (see, for example, the mesh 132of the implant 130) and may span only a part of the region circumscribedby the frame 4. Another exemplary modification may include forming anotch (similar to the notch 142A of the mesh 142 of implant 140) in theproximal end of any of the implants 20, 30, 90, 100, 120 and 160, ifdesired. Thus, any such type of modification of any one of the abovedisclosed implants by adding (or subtracting) or suitably modifying oneor more components of the implant embodiments disclosed herein isincluded within the scope of the implants of the present applicationunless they result in physically or structurally incompatible componentsor unless such modifications are mutually exclusive.

It is further noted that while some exemplary embodiment of the implantsdisclosed hereinabove use a mesh attached to a frame, any of theseembodiments may also use a sheet as defined hereinabove. In suchembodiments if a sheet is used, any connecting members which passthrough openings in the mesh may pass through suitable openings formedin the perimeter of the sheet, and such openings in the sheet are madein the perimeter of the sheet such that they may be aligned to match theposition of the connecting members. Alternatively, some of the implantsmay use a sheet comprising a contiguous membrane with no openings. Forexample, in implants having two half frames with protruding connectingmembers and matching recesses or passages (such as, for example, theimplants 30, 50, 60 and 70), the connecting members may punch holesthrough the contiguous sheet or membrane when the male and female halfframes are pressed to each other during the assembly of the implant. The“punching” of such holes in the sheet or membrane by any of suchprotruding members may simplify the assembly of the implants because itmay eliminate the need to precisely align pre-formed holes in the sheetwith the protruding connecting members. The feasibility of such a holepunching method may depend, inter alia, on the thickness, strength andother mechanical and thermal properties of the membrane or sheet beingused, and may be possible irrespective of the method of attachment beingused (such methods may include but are not limited to, thermal bonding,thermal nailing, ironing, ultrasonic welding, and suitable mechanical“ball and socket” type or “snap in” methods, as disclosed hereinabove).

A method for treating bladder prolapse is described with reference toFIGS. 28-30. A patient is set up for surgery, placed in a gynecologicalposition, and anesthetized. A weighted speculum is placed in the lowervaginal wall to expose the prolapsed upper vaginal wall. An incision ismade along the center of the upper wall of the vagina 123. In apreferred embodiment, the incision is approximately 1 mm deep and 4 cmlong. Using a sharp instrument such as a scissor, the vagina 123 isseparated from the bladder wall through the initial incision.Alternatively, the vagina 123 may be separated from the wall of thebladder 110 using blunt dissection—such as with the tip of a finger.These types of incisions and separations are well-known in the art, andthe methods of the present invention are not limited to the detailsincluded herein. An implant (such as, for example, the implant 120 ofFIG. 28) may be compressed and inserted through an incision in thevagina 123 and situated between the vagina 123 and the bladder 110. Theimplant 120 may then expanded into its fully relaxed state (if theimplant is a non-tensioned implant) or into its partially relaxed state(if the implant is a pre-tensioned implant as disclosed hereinabove),wherein the arms 124A and 124B are situated close to the pelvicsidewalls (not shown) alongside the Arcus Tendenius Pelvis Fascia (notshown) without tension or with gentle tension holding it in place. Thevaginal incision is then sutured closed under the implanted implant 120.As shown in FIG. 28, the implant 120 is situated between the vagina 123and the bladder 110, supporting the bladder 110 and preventing it fromdescending (prolapsing) onto the vaginal canal.

In an alternative embodiment, an incision is made between the vagina 123and the rectum (not shown), and device 120 is inserted into a positionthat provides support of the rectum (not shown), with the framecompressed against a para-rectal compartment (not shown). In thisembodiment, the implant 120 would be similar in shape, but generallydifferent in size than device 120 used for bladder support.

Returning to FIG. 29, in an alternative embodiment, if the implant 140is used, the bent arm portions and the notch 142A in the mesh 142 may bepositioned adjacent the cervix 117 to improve support.

Turning to FIG. 30, in an alternative embodiment if the implant 164 isimplanted in a patient, the first sheet 162 is placed between the vagina123 and the bladder 110 and supports the bladder 110 and the second(strap-like) sheet 168 held by the third and fourth arms 164C and 164Dis placed between the wall of the vagina 123 and the urethra 112. Thisarrangement is particularly advantageous in cases of patients in whichPOP is combined with SUI since the support of the second sheet 168improves support of the urethra 112 and may therefore reduce oreliminate urine leakage in cases of SUI.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

It is noted that any of the implants disclosed in the presentapplication may also be used for the treatment of hernia of theabdominal wall, or diaphragmatic hernia, or inguinal hernia by suitablymodifying or adapting the shape and/or dimensions, and/or curvature orany other parameter of the implant to fit the type of treatment, suchmodifications will be apparent to the person skilled in the art and aretherefore not disclosed in detail herein.

It is also noted that in accordance with additional embodiments of theimplants of the present application, the arms of the frame of theimplant may be configured as several types of arms. For example, any ofthe first and the second arm of the implants may be configured anarticulated arm or a segmented arm, or an arm formed as an integral partof the frame, or an arm that is attached to said frame. Such articulatedor segmented arms may enable more freedom in shaping the implant duringimplantation.

In attached arms, the arms may be formed as a separate part of the frameand may be attached to the frame of the implant when the frame isassembled by using any attachment type known in the art, including butnot limited to a ball and socket type of attachment mechanism, ascrew-like attachment mechanism, gluing, ultrasonic welding, thermalwelding or any other suitable type of attachment mechanism or attachmentmethod known in the art.

Similarly, if the implant is of the type that has four arms (such as theexemplary implant 160 of FIG. 30), any of the first arm, second arm,third arm and fourth arm may be configured as an articulated arm or asegmented arm or an arm formed as an integral part of said frame or anarm that is attached to said frame, as disclosed hereinabove. Forexample, in an implant of the type illustrated in FIG. 30, if the thirdand fourth arm may be attachable arms that may be attached to theimplant at any stage of the assembly of the implant. This type ofattachable arm may be useful in cases in which the first sheet of theimplant (such as, for example, the first sheet 162) needs to be attachedto the first arm 164A and the second arm 164B before the second sheet(such as, for example the second sheet 168) is attached to the third andfourth arms 164C and 164D. In such a case, the first sheet 162 may befirst attached to the first arm 164A and the second arm 164D by usingany of the attachment methods disclosed hereinabove and after the firstsheet 162 is attached to the arms 164A and 164B (either under tension orwithout being under tension), the third and fourth arms (such as forexample the arms 164C and 164D) of the implant may be attached to theimplant by any suitable method of attaching or mechanism for attachmentas disclosed in detail hereinabove.

It is further noted that in implants having four arms (such as forexample the implant 160), the first sheet and the second sheet of theimplant need not necessarily be attached to the arms using the sameattachment method. For example, in an embodiment of the implant, thefirst sheet 162 may be attached to the first and second arms usingultrasonic welding, while the second sheet 168 may be attached to thethird and fourth arms by inserting the third and fourth arms 164C and164D into sleeves formed in the second sheet, as disclosed in detailhereinabove and illustrated in FIG. 24. In another embodiment of theimplant, the first sheet 162 may be attached to the first and secondarms 164A and 164B by using the sheet attachment method and the armconfiguration disclosed in detail with respect to the implant 130 ofFIGS. 25 and 26 while the second sheet 168 may be attached to the thirdand fourth arms 164C and 164D by ironing. It is therefore noted that inthe implants having four arms of the present application any of theattachment methods disclosed hereinabove may be used for attaching thefirst sheet of the implant to the first and second arm of the implantand any of the attachment methods disclosed hereinabove may be used forattaching the second sheet of the implant to the third and fourth arm ofthe implant. Any possible combination and permutation of attachmentmethods of the first and second sheets of the same implant and of thearms' structure and configuration may be possible and may be practicedin the implants of the present application.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

It is noted that while the novel method of thermal bonding disclosedhereinabove was demonstrated for use in pelvic implants, it is by nomeans limited to such specific implants. Rather, the method may begenerally applies to any implant requiring securing a sheet or mesh to asupporting frame of any shape by thermal bonding methods such asultrasonic welding. In a non-limiting example, the method may be usedfor constructing breast implants usable for breast shape reconstructivesurgery and for any other types of surgical implants including a sheetor a mesh held by a frame.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

What is claimed is:
 1. A device for implantation in a pelvis, the devicecomprising: a sheet having a perimeter; and a frame comprising anelastic member having a first arm and a second arm, said member has acompressed state and a relaxed state, said member being elasticallybendable to change the distance between said first arm and said secondarm, said frame holds said sheet at a portion of said perimeter suchthat in an assembled device said sheet is held under tension.
 2. Thedevice according to claim 1, wherein said frame has contoured lateraledges.
 3. The device according to any of claims 1-2, wherein said deviceis a flat device and said frame is flat frame.
 4. The device accordingto any of claims 1-2, wherein said device is a curved non-planar device,said frame is a non-planar frame, wherein said first arm and said secondarm are curved to fit a curved pelvic region defined between a vaginaand an organ of said pelvis.
 5. The device according to according toclaim 4, wherein said organ is a bladder and said first arm and secondarm are curved to fit a curved pelvic region defined between said vaginaand said bladder.
 6. The device according to claim 4, wherein said organis a rectum and said first arm and second arm are curved to fit a curvedpelvic region defined between said vagina and said rectum.
 7. The deviceaccording to claim 1, wherein said frame has a proximal portion and adistal portion, said first arm and said second arm each have a proximalportion and a distal portion, and wherein the proximal portions of saidfirst arm and said second arm are bent towards each other at an angle.8. The device according to claim 7, wherein said angle is selected froma right angle, an acute angle and an obtuse angle.
 9. The deviceaccording to any of the preceding claims, wherein said sheet is selectedfrom the group consisting of a mesh, a sheath, a diaphragm, a membrane,a multi-layered sheet and a divider.
 10. The device according to any ofclaims 1-3 and 7-9, wherein said sheet has a substantially flatconfiguration.
 11. The device according to any of claims 4-9, whereinsaid sheet has a non-planar configuration.
 12. The device according toany of the preceding claims, wherein said sheet is a biocompatible sheetcomprising a material selected from the group consisting of a syntheticmaterial, a polymer based material, a biological material, a collagen, abiodegradable material, and any combinations thereof.
 13. The deviceaccording to any of the preceding claims, wherein in said assembleddevice a restoring force applied by said first arm and said second armto said sheet to hold said sheet under tension is in the range of0.001-2 Newton.
 14. The device according to any of the preceding claims,wherein said frame has a first configuration in which said frame iscompressed, causing said sheet to be configured in a compressedposition, and said frame has a second configuration in which said frameis expanded, to allow said sheet to be configured in an expandedposition, and wherein in said expanded position said sheet is under saidtension.
 15. The device according to any of the preceding claims,wherein said frame comprises a first half frame and a second half frameattachable to said first half frame.
 16. The device according claim 15,wherein said first half frame has a plurality of recesses formed in afirst side of said first half frame and said second half frame has aplurality of protruding connecting members disposed on a first side ofsaid second half frame, said protruding connecting members arepositioned on said second half frame to match the positions of saidrecesses of said first half-frame.
 17. The device according to claim 16,wherein said protruding connecting members are shaped to engage with astep formed in each of said recesses.
 18. The device according to any ofclaims 16-17, wherein at least some of said recesses have an openpassage formed therein opening on the surface of a second side of saidfirst half frame and wherein said open passage is shaped to allow an endof a connecting member to protrude beyond the surface of a second sideof said second half frame when a connecting member is inserted into saidopen passage to allow attaching of said first and said second halfframes by thermal and/or ultrasonic welding applied to the end of saidconnecting member protruding beyond the surface of said second side ofsaid second half frame.
 19. The device according to claim 16, wherein atleast some of said recesses are shaped to receive said protrudingconnecting members therein and to hold said connecting members in acaptive manner when said first half frame and said second half frame arealigned and pushed together.
 20. The device according to claim 19,wherein said first half frame has a first side said recesses beingformed in said first side and a second side having a surface, andwherein at least some of said recesses have an open passage formedtherein, said open passage opens on said surface of said second side andwherein said open passage is shaped to allow an end of a connectingmember to be inserted into said open passage and to be captively heldwithin said open passage after insertion.
 21. The device according toclaim 20, and wherein said passage comprises a first passage portioncommunicating with said recess and a second passage portion wider thansaid first passage portion and opening on said surface and wherein atleast some of said connecting members have a slotted end to allowforcing said slotted end through said first passage portion into saidsecond passage portion, wherein said slotted end expands within saidsecond passage portion to hold said connecting member captive withinsaid second passage portion.
 22. The device according to claim 1,wherein said sheet comprises a first sleeve formed at a first side ofsaid perimeter for receiving said first arm therein and a second sleeveformed on a second side of said perimeter for receiving said second armtherein.
 23. The device according to claim 22, wherein said first sleeveand said second sleeve are formed by folding end portions of said sheetat said first side and at said second side and attaching at least partof the folded end portions to the surface of said sheet to form saidfirst sleeve and said second sleeve.
 24. The device according to any ofclaims 22-23, wherein said first and second sleeves are formed in saidsheet prior to inserting said first arm and said second arm therein andwherein the distance between said first sleeve and said second sleeve issuch that said first arm and said second arm are bent towards each otherprior to inserting said first arm and said second arm into said firstsleeve and said second sleeve, respectively, to achieve said tensionedstate of said sheet.
 25. The device according to any of claims 22-23,wherein said first sleeve and said second sleeve are formed by foldingportions of the perimeter of said sheet over the said first and saidsecond arms and attaching said portions to the surface of said sheet,while said frame is in as compressed state.
 26. The device according toany of the preceding claims, wherein said sheet is a first sheet, andwherein said frame also includes a third arm and a fourth arm andwherein said device includes a second sheet attached to said third armand to said fourth arm for supporting a neck of a bladder and/or aurethra from prolapsing into the wall of a vagina.
 27. The deviceaccording to claim 26, wherein the area of said second sheet is smallerthan the area of said first sheet.
 28. The device according to any ofclaims 26-27, wherein said first sheet is configured for implantation insaid pelvis between a vagina and a bladder.
 29. The device according toclaim 28, wherein said first sheet is configured to be disposed betweensaid bladder and said vagina and said second sheet is configured to bedisposed between said vagina and a bladder neck and/or an urethra. 30.The device according to any of claims 26-29, wherein at least one ofsaid first sheet and said second sheet is selected from the groupconsisting of a mesh, a sheath, a diaphragm, a membrane, a divider and amulti-layer sheet.
 31. The device according to any of claims 26-30,wherein at least one of said first sheet and said second is abiocompatible sheet comprising a material selected from the groupconsisting of a synthetic material, a polymer based material, acollagen, a biological material, a biodegradable material, and anycombinations thereof.
 32. The device according to any of claims 26-31,wherein at least one of said first sheet and said second sheet is anelastic sheet or a flexible sheet.
 33. The device according to any ofclaims 26-32, wherein said frame has a first configuration in which saidframe is compressed, causing said first sheet and said second sheet tobe in a non-tensioned state, and a second configuration in which saidframe is expanded, to allow said first sheet and said second sheet to bein a tensioned state.
 34. The device according to any of claims 26-32,wherein said first arm said second arm said third arm and said fourtharm are selected from the group consisting of: one or more of said firstarm said second arm said third arm and said fourth arm being integralportions of said frame; one or more of said first arm said second armsaid third arm and said fourth arm being an attachable part attached ofsaid frame; and one or more of said first arm said second arm said thirdarm and said fourth arm being articulated parts of said frame.
 35. Thedevice according to any of claims 26-34, wherein in the assembled devicesaid first sheet and said second sheet are held under tension.
 36. Thedevice according to any of claims 26-35, wherein in the assembled devicesaid first sheet is held under tension while said second sheet is notheld under tension in the assembled device.
 37. The device according toany of claims 26-34, wherein in the assembled device said first sheet isheld under tension while said second sheet is loose.
 38. The deviceaccording to any of claims 26-37, wherein said frame comprises a firsthalf frame and a second half frame attached to each other for supportingsaid first sheet and said second sheet.
 39. The device according toclaim 38, wherein at least one of said first sheet and said second sheetis held between said first half frame and said second half frame. 40.The device according to claim 38, wherein at least one of said firstsheet and said second sheet is attached to said frame by sleeves formedin the perimeter of said at least one of said first sheet and saidsecond sheet.
 41. A method for treating prolapse of a pelvic organ, themethod comprising: providing a device according to any of claims 1-40;compressing said frame into a first compressed configuration;introducing said device through a vagina; inserting said device into aspace between said vagina and said pelvic organ; and expanding saidframe into a partially relaxed configuration, wherein in said partiallyrelaxed configuration said sheet is held under tension.
 42. The methodaccording to claim 41, wherein said expanding also includes anchoringsaid frame into an anatomical structure.
 43. The method according to anyof claims 41-42, wherein said compressing comprises elastically bendingat least a portion of said frame.
 44. The method according to claim 43,wherein said expanding comprises unbending said at least a portion ofsaid frame.
 45. The method according to any of claims 41-44, whereinsaid pelvic organ is a bladder and wherein said inserting comprisesinserting said device into a space between said vagina and said bladder.46. The method according any of claims 42-45, wherein said anatomicalstructure is a pelvic side-wall.
 47. The method according to any ofclaims 42-44, wherein said pelvic organ is a rectum and wherein saidinserting comprises inserting said device into a space between saidvagina and said rectum.
 48. The method according to claim 47, whereinsaid anatomical structure is a para-rectal compartment.
 49. A device forimplantation in a pelvis, the device comprising: a sheet having aperimeter; and an elastic frame having a first arm and a second arm, forholding said sheet at a portion of said perimeter, wherein said deviceis a curved non-planar device and wherein said first arm and said secondarm are curved to fit a curved pelvic region defined between a vaginaand an organ of said pelvis.
 50. The device according to claim 49,wherein said frame has laterally contoured edges.
 51. The deviceaccording to any of claims 49-50, wherein said organ is a bladder andsaid first arm and second arm are curved to fit a curved pelvic regiondefined between said vagina and said bladder.
 52. The device accordingto any of claims 49-50, wherein said organ is a rectum and said firstarm and second arm are curved to accommodate a curved pelvic regiondefined between said vagina and said rectum.
 53. The device according toany of claims 49-52, wherein said sheet is a first sheet, wherein saidframe also includes a third arm and a fourth arm, and wherein saiddevice comprises a second sheet attached to said third arm and to saidfourth arm for supporting a neck of a bladder and/or an urethra fromprolapsing into the wall of said vagina.
 54. The device according toclaim 53, wherein the area of said second sheet is smaller than the areaof said first sheet.
 55. The device according to claim 53, wherein saidfirst sheet is configured for implantation in said pelvis between avagina and a bladder.
 56. The device according to claim 53, wherein saidfirst sheet is configured to be disposed between a bladder and saidvagina and said second sheet is configured to be disposed between saidvagina and a bladder neck and/or an urethra.
 57. The device according toany of claims 53-56, wherein said second sheet is selected from thegroup consisting of a mesh, a sheath, a diaphragm, a membrane, a dividerand a multi-layer sheet.
 58. The device according to any of claims53-57, wherein said second sheet is a biocompatible sheet comprising amaterial selected from the group consisting of a synthetic material, apolymer based material, a biological material, a collagen, abiodegradable material, and any combinations thereof.
 59. The deviceaccording to any of claims 53-58, wherein said second sheet comprises anelastic and/or a flexible sheet.
 60. The device according to any ofclaims 53-59, wherein said frame has a first configuration in which saidframe is compressed, causing said first sheet and said second sheet tobe in a non-tensioned state, said frame has a second configuration inwhich said frame is expanded to allow said first sheet and said secondsheet to be in a tensioned state.
 61. The device according to any ofclaims 53-60, wherein said first arm said second arm said third arm andsaid fourth arm are selected from the group consisting of: one or moreof said first arm said second arm said third arm and said fourth armbeing integral portions of said frame; one or more of said first armsaid second arm said third arm and said fourth arm being an attachablepart attached of said frame; and one or more of said first arm saidsecond arm said third arm and said fourth arm being articulated parts ofsaid frame.
 62. The device according to any of claims 53-61, wherein inthe assembled device, at least one of said first sheet and said secondsheet is held under tension.
 63. The device according to any of claims53-62, wherein in the assembled device said first sheet is held undertension while said second sheet is not held under tension.
 64. Thedevice according to any of claims 53-63, wherein said frame comprises afirst half frame and a second half frame attached to each other forsupporting said first sheet and said second sheet.
 65. The deviceaccording to claim 64 wherein at least one of said first sheet and saidsecond sheet is held between said first half frame and said second halfframe.
 66. The device according to any of claims 53-63, wherein at leastone of said first sheet and said second sheet is attached to said frameby sleeves formed in the perimeter of said at least one of said firstsheet and said second sheet.
 67. The device according to any of claims49-66, wherein said first arm and said second arm each has a proximalportion and a distal portion, and wherein the proximal portions of saidfirst arm and said second arm are bent towards each other at an angle.68. The device according to claim 67, wherein said angle is selectedfrom a right angle, an acute angle and an obtuse angle.
 69. The deviceaccording to claim 49, wherein said sheet is selected from the groupconsisting of a mesh, a sheath, a diaphragm, a membrane, a multi-layeredsheet and a divider.
 70. The device according to claim 49, wherein saidsheet is a biocompatible sheet comprising a material selected from thegroup consisting of a synthetic material, a polymer based material, abiological material, a biodegradable material, a collagen, and anycombinations thereof.
 71. The device according to any of claims 49-70,wherein said frame comprises at least one elastic material.
 72. Thedevice according to any of claims 49-71, wherein in the assembled devicesaid sheet is held under tension by said first arm and said second armto reduce sagging of said sheet and organ prolapse after implantation.73. The device according to any of claims 49-72, wherein said frame hasa first configuration in which said frame is compressed, causing saidsheet to be configured in a relaxed state, said frame has a secondconfiguration in which said frame is expanded, to allow said sheet to beconfigured in an tensioned state, and wherein in said tensioned statesaid sheet is under said tension.
 74. The device according to any ofclaims 49-73, wherein in said assembled device a restoring force appliedby said first arm and said second arm to said sheet to hold said sheetunder tension is in the range of 0.001-2 Newton.
 75. The deviceaccording to any claims 49-74, wherein said frame comprises a first halfframe and a second half frame attachable to said first half frame. 76.The device according to claim 75, wherein said first half frame has aplurality of recesses formed on a first side of said first half frameand said second half frame has a plurality of protruding connectingmembers disposed on a second side of said second half frame, saidprotruding connecting members are positioned on said second half frameto match the positions of said recesses of said first half-frame. 77.The device according to claim 76, wherein said protruding connectingmembers are shaped to engage with a step formed in each of saidrecesses.
 78. The device according to claim 76, wherein said recesseshave an open passage formed therein opening on the surface of a secondside of said first half frame and wherein said open passage is shaped toallow an end of a connecting member to protrude beyond the surface of asecond side of said second half frame when a connecting member isinserted into said open passage, to allow attaching of said first andsaid second half frames by thermal bonding and/or ultrasonic weldingapplied to the end of said connecting members protruding beyond thesurface of said first side of said second half frame.
 79. The deviceaccording to claim 76, wherein said recesses are shaped to receive saidprotruding connecting members therein and to hold said connectingmembers in a captive manner when said first half frame and said secondhalf frame are aligned and pushed together.
 80. The device according toclaim 76, wherein said first half frame has a first side said recessesbeing formed in said first side and a second side having a surface, andwherein each of said recesses has an open passage formed therein, saidopen passage opens on said surface of said second side and wherein saidopen passage is shaped to allow an end of a connecting member to beinserted into said open passage and to be held in a captive mannerwithin said open passage after insertion.
 81. The device according toclaim 80, and wherein said passage comprises a first passage portioncommunicating with said recess and a second passage portion wider thansaid first passage portion and opening on said surface and wherein atleast some of said connecting members have a slotted end to allowforcing said slotted end through said first passage portion into saidsecond passage portion, wherein said slotted end expands within saidsecond passage portion to hold said connecting member captive withinsaid second passage portion.
 82. The device according to claim 49,wherein said sheet comprises a first sleeve formed at a first side ofsaid perimeter for receiving said first arm therein and a second sleeveformed on a second side of said perimeter for receiving said second armtherein.
 83. The device according to claim 82, wherein said first sleeveand said second sleeve are formed by folding end portions of said sheetat said first side and at said second side and attaching at least partof the folded end portions to the surface of said sheet to form saidfirst sleeve and said second sleeve.
 84. The device according to any ofclaims 82-83, wherein said first sleeve and second sleeve are formed insaid sheet prior to inserting said first arm and said second armtherein, respectively, and wherein the distance between said firstsleeve and said second sleeve is such that said first arm and saidsecond arm are bent towards each other prior to inserting said first armand said second arm into said first sleeve and said second sleeve,respectively, for holding said sheet under tension after said first armand said second arms are unbent.
 85. The device according to any ofclaims 83-84, wherein said first arm and said second arm are elasticallybent towards each other to reach a compressed state of said frame andwherein one or more sleeves of said first sleeve and said second sleeveis formed by folding a portion of the perimeter of said sheet over therespective arm of said first and second arms and attaching said portionto the surface of said sheet while said frame is in a compressed stateand wherein said frame is relaxed into a tensioned state of said sheet.86. The device according to claim 85, wherein said at least one of saidfirst sleeve and said second sleeve comprise both of said first sleeveand said second sleeve and wherein said first sleeve is formed byfolding a first portion of the perimeter of said sheet over said firstarm and attaching said first portion to the surface of said sheet andsaid second sleeve is formed by folding a second portion of theperimeter of said sheet over said second arm and attaching said secondportion to the surface of said sheet while said frame is in a compressedstate and wherein said frame is relaxed to form said tensioned state ofsaid sheet.
 87. A method for treating prolapse of a pelvic organ, themethod comprising: providing a device according to any of claims 49-86;compressing said frame into a first compressed configuration;introducing said device through a vagina; inserting said device into aspace between said vagina and said pelvic organ; and expanding saidframe into a second partially relaxed or fully relaxed configuration.88. The method according to claim 87, wherein said method also comprisesanchoring said frame into an anatomical structure.
 89. The methodaccording to any of claims 87-88, wherein said compressing compriseselastically bending at least a portion of said frame.
 90. The methodaccording to claims 87-88, wherein said expanding comprises unbendingsaid at least a portion of said frame.
 91. The method according to anyof claims 87-90, wherein said inserting comprises inserting said deviceinto a space between said vagina and a bladder.
 92. The method of any ofclaims 88-91, wherein said anatomical structure is a pelvic side-wall.93. The method according to any of claims 88-90, wherein said insertingcomprises inserting said device into a space between said vagina and arectum and wherein said anatomical structure is a para-rectalcompartment.
 94. A method for attaching a sheet to a supporting frame ofan implant, the method comprising; providing an elastic frame having afirst arm and a second arm, said frame having a relaxed configuration, acompressed configuration and a partially relaxed configuration;attaching said sheet to said frame when said frame is in said compressedconfiguration; and allowing said frame to relax until the relaxing ofsaid frame is stopped by said sheet while said frame is at a partiallyrelaxed configuration, wherein said frame and said sheet are configuredsuch that when said frame is in said partially relaxed configurationsaid sheet is held under tension.
 95. The method according to claim 94,wherein said sheet is selected from the group consisting of a mesh, asingle sheet, a multilayered sheet, a diaphragm, a membrane and adivider.
 96. The method according to any of claims 94-95, wherein saidframe comprises a first half frame and a second half frame and whereinsaid attaching comprises disposing said sheet between said first halfframe and said second half frame and attaching said first half frame tosaid second half frame while said sheet is held between said first halfframe and said second half frame and while said first half frame andsaid second half frame are in a compressed configuration.
 97. The methodaccording to claim 96, wherein said first half frame comprises aplurality of recesses or through passages formed therein and said secondhalf frame has a plurality of protruding connecting members and whereinsaid attaching comprises inserting said plurality of protrudingconnecting members through a plurality of openings formed in said sheetand into said plurality of recesses or passages of said first half frameand firmly attaching said first half frame to said second half frame.98. The method according to claim 97, wherein said firmly attaching isselected from the group consisting of mechanically attaching said firsthalf frame to said second half frame, thermally bonding said first halfframe to said second half frame, ultrasonically welding said first halfframe to said second half frame and gluing said first half frame to saidsecond half frame.
 99. The method according to claim 98, wherein saidmechanically attaching comprises attaching said first half frame to saidsecond half frame.
 100. The method according to any of claims 94-95,wherein said attaching comprises inserting said first arm into a firstsleeve formed in a first portion of the perimeter of said sheet andinserting said second arm into a second sleeve formed in a secondportion of said perimeter of said sheet.
 101. A method for attaching asheet to a supporting frame of an implant, the method comprising:providing a first half frame having a plurality of recesses formedtherein; providing a second half frame having a plurality of protrudingconnecting members disposed on said second half frame, said protrudingconnecting members are positioned to match the position of said recessesof said first half-frame; providing a sheet having a perimeter and aplurality of openings formed in said sheet, at least some of saidopenings are positioned to match the position of said protrudingconnecting members; inserting said plurality of protruding connectingmembers through said plurality of openings of said sheet into matchingrecesses of said plurality of recesses; and ultrasonically welding saidfirst half-frame to said second half frame by applying ultrasonic energyto at least one of said first half frame and said second half frame, toselectively melt a portion of each of said connecting members to firmlyattach said first and second half-frames to each other without thermallydamaging said sheet.
 102. The method according to claim 101, whereineach of said recesses comprises an open passage passing through saidfirst half frame, said passage is configured to allow a connectingmember of said connecting members to be inserted therethrough such thatthe end of said connecting member protrudes beyond the end of said openpassage, and wherein said ultrasonic welding is performed by selectivelyapplying ultrasonic energy to an end of each of said connecting membersthat protrudes beyond an open end of said passage to widen saidprotruding end for firmly attaching said first half frame to said secondhalf frame without thermally damaging said sheet.
 103. A method forattaching a sheet to a supporting frame of an implant, the methodcomprising the steps of: providing a first half frame having a firstsurface, said first half frame comprises a plurality of recesses formedin said first surface; providing a second half frame having a secondsurface comprising a plurality of protruding connecting members disposedon said second surface, said protruding connecting members arepositioned to match the position of said recesses of said firsthalf-frame, said connecting members and said recesses are configuredsuch that when said connecting members are fully inserted into saidrecesses, said first surface and said second surface have a gaptherebetween; providing a sheet having a perimeter and a plurality ofopenings formed in said sheet, at least some of said openings arepositioned to match the position of said protruding connecting members,wherein the thickness of said sheet is smaller than the width of saidgap; inserting said plurality of protruding connecting members throughat least some of said plurality of openings into matching recesses ofsaid plurality of recesses; applying ultrasonic energy to at least oneof said first half frame and said second half frame to selectively heatat least portions of said connecting members and said recesses; andapplying force to at least one of said first half frame and said secondhalf frame to firmly weld said connecting members to said recesses. 104.The method according to claim 103, wherein said step of applyingultrasonic energy comprises applying a pulse of ultrasonic energy. 105.The method according to claim 104, wherein said pulse of ultrasonicenergy has a duration in the range of 0.1-2 seconds.
 106. The methodaccording to any of claims 104-105, wherein said step of applying forcebegins prior to the step of applying ultrasonic energy.
 107. The methodaccording to any of claims 103-105, wherein said step of applying forceand said step of applying ultrasonic energy are performedsimultaneously.
 108. The method according to any of claims 104-105,wherein said pulse of ultrasonic energy is terminated before said stepof applying force begins, to avoid thermal damage to said sheet. 109.The method according to any of claims 103-108, wherein the methodincludes the step of compressing said first half frame and said secondhalf frame into a compressed state prior to performing said step ofinserting.
 110. The method according to any of claims 103-109, whereinsaid first half frame and said second half frame comprise PEEK having amelting temperature of about 340° C. and said sheet comprisespolypropylene having a melting temperature of about 130° C.
 111. Adevice for implantation in a pelvis, the device comprising: a firstsheet having a first perimeter and a second sheet having a secondperimeter; and a frame for holding said first sheet at a portion of saidfirst perimeter, and for holding said second sheet at a portion of saidsecond perimeter wherein said frame comprises a first arm, a second arm,a third arm and a fourth arm, wherein said first arm and said second armhold said first sheet along at least a portion of said first perimeterand wherein said third arm and said fourth arm hold said second sheetalong at least a portion of said second perimeter.
 112. The deviceaccording to claim 111, wherein the area of said second sheet is smallerthan the area of said first sheet.
 113. The device according to any ofclaims 111-112, wherein said first sheet is configured for implantationin said pelvis between a vagina and a bladder.
 114. The device accordingto claim 113, wherein said first sheet is configured to be disposedbetween said bladder and said vagina and said second sheet is configuredto be disposed between said vagina and a bladder neck and/or an urethra.115. The device according to any of claims 111-114, wherein said firstsheet and said second sheet are selected from the group consisting of amesh, a sheath, a diaphragm, a membrane, a divider and a multi-layersheet.
 116. The device according to any of claims 111-115, wherein saidfirst sheet and said second sheet are biocompatible sheets comprising amaterial selected from the group consisting of a synthetic material, apolymer based material, a biological material, a collagen, abiodegradable material, and any combinations thereof.
 117. The deviceaccording to any of claims 111-116, wherein said frame comprises anelastic frame or a flexible frame.
 118. The device according to any ofclaims 111-117, wherein said frame has a first configuration in whichsaid frame is compressed, causing said first sheet and said second sheetto be configured in a compressed position, and said frame has a secondconfiguration in which said frame is expanded, to allow said first sheetand said second sheet to be configured in an expanded position.
 119. Thedevice according to any of claims 111-118, wherein said first arm saidsecond arm said third arm and said fourth arm are selected from thegroup consisting of: one or more of said first arm said second arm saidthird arm and said fourth arm is an integral portion of said frame; oneor more of said first arm said second arm said third arm and said fourtharm is an attachable part attached of said frame; and one or more ofsaid first arm said second arm said third arm and said fourth arm is anarticulated part of said frame.
 120. The device according to any ofclaims 111-119, wherein in the assembled device, at least one of saidfirst sheet and said second sheet is held under tension.
 121. The deviceaccording to any of claims 111-118, wherein in the assembled device saidfirst sheet is held under tension while said second sheet is not heldunder tension.
 122. The device according to any of claims 111-121,wherein said frame comprises a first half frame and a second half frameattached to each other for supporting said first sheet and said secondsheet.
 123. The device according to claim 122, wherein at least one ofsaid first sheet and said second sheet is held between said first halfframe and said second half frame.
 124. The device according to any ofclaims 111-122, wherein at least one of said first sheet and said secondsheet is attached to said frame by sleeves formed in the perimeter ofsaid at least one of said first sheet and said second sheet.
 125. Thedevice according to any of claims 1 and 49, wherein said sheet alsoincludes or is coated with a material selected from the group consistingof a drug, a pharmaceutically active composition, a biologically activematerial, an anti inflammatory agent, an anti-bacterial agent, an antiviral agent, an antibiotic agent, a hormone, a biologically activeprotein, a biologically active polypeptide, a collagen, metallic ions,enzymes, enzyme precursors, biological promoters, a slow release matrixcontaining any therapeutic agent, and/or pharmaceutical agent and/orbiologically active material, a gel matrix containing any therapeuticagent, and/or pharmaceutical agent and/or biologically active materialand any combination thereof.
 126. The device according claim 111,wherein at least one of said first sheet and said second sheet alsoincludes or is coated with a material selected from the group consistingof a drug, a pharmaceutically active composition, a biologically activematerial, an anti inflammatory agent, an anti-bacterial agent, an antiviral agent, an antibiotic agent, a hormone, a biologically activeprotein, a biologically active polypeptide, a collagen, metallic ions,enzymes, enzyme precursors, biological promoters, a slow release matrixcontaining any therapeutic agent, and/or pharmaceutical agent and/orbiologically active material, a gel matrix containing any therapeuticagent, and/or pharmaceutical agent and/or biologically active materialand any combination thereof.
 127. The device according to any of claims1, 49 and 111, wherein said frame comprises a material selected from thegroup consisting of a polymer, a metal, a biocompatible material PEEK,shape memory PEEK, polylactic acid, polyethylene glycol, a syntheticbiomaterial, titanium, stainless steel, a shape-memory alloy, and anycombination thereof.
 128. The device according to any of claims 1 and49, wherein one or more of said first arm and said second arm areselected from the group consisting of articulated arms, segmented arms,arms formed as an integral part of said frame, arms that are attached tosaid frame.
 129. The device according to claim 111, wherein one or moreof said first arm, said second arm, said third arm and said fourth armis selected from the group consisting of an articulated arm, a segmentedarm, an arm formed as an integral part of said frame, an arm that isattached to said frame.
 130. The device according to any of claims 1-2,wherein said device is a non-planar device, wherein said frame is anon-planar frame and wherein said first arm and said second arm arerostro-caudally convex arms.
 131. The device according to any of claims1-2, wherein said device is a non-planar device, wherein said frame is anon-planar frame and wherein said first arm and said second arm arerostro-caudally concave arms.
 132. The device according to any of claims49-50, wherein said organ is a bladder and said first arm and second armare rostro-caudally convex to fit a curved pelvic region defined betweensaid vagina and said bladder.
 133. The device according to any of claims49-50, wherein said organ is a rectum and said first arm and second armare rostro-caudally concave to accommodate a curved pelvic regiondefined between said vagina and said rectum.